Hedron
Hedron Lumbar Spacers are interbody devices used to provide structural stability following discectomy. The filing describes different spacer shapes for anterior, anterolateral, lateral,…
Hedron Lumbar Spacers are interbody devices used to provide structural stability following discectomy. The filing describes different spacer shapes for anterior, anterolateral, lateral, posterior or transforaminal approaches in the lumbar spine.
The FDA indication covers specified thoracic, thoracolumbar junction and lumbosacral levels as an adjunct to fusion for listed conditions. Patients are to be skeletally mature and have had at least six months of non-operative treatment.
Listed Item
Locking Bone Screw, Self-Drilling 5.5mm, 30mm
Materials and Use
The summary says the spacers are additively manufactured from titanium powder. It also states that they are filled with autograft or allogenic bone graft and used with supplemental fixation systems cleared for the thoracolumbosacral spine.
14manufacturers in China registered for this device type
185catalogue numbers in this listing
20510(k) clearances naming this product code
22recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K191391 |
| Record published | 2022-02-01 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 30 to 39 mm; angle 8 to 30 °; height 13 to 21 mm; depth 24 to 29 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1225.1017S | In distribution | |
| 1209.0959S | In distribution | |
| 1210.0156S | In distribution | |
| 1209.0317S | In distribution | |
| 1209.2149S | In distribution | |
| 1209.2049S | In distribution | |
| 1210.1256S | In distribution | |
| 1209.0259S | In distribution | |
| 1209.2071S | In distribution | |
| 1210.2150S | In distribution | |
| 1209.2091S | In distribution | |
| 7212.1030 | In distribution | |
| 1210.1255S | In distribution | |
| 1210.0214S | In distribution | |
| 1225.1010S | In distribution | |
| 1210.0217S | In distribution | |
| 1209.2113S | In distribution | |
| 1210.0253S | In distribution | |
| 1210.2291S | In distribution | |
| 1210.0115S | In distribution | |
| 1210.0151S | In distribution | |
| 1209.0319S | In distribution | |
| 1209.2015S | In distribution | |
| 1209.0285S | In distribution | |
| 1209.2035S | In distribution | |
| 1210.0109S | In distribution | |
| 1210.1151S | In distribution | |
| 1210.2188S | In distribution | |
| 1209.0277S | In distribution | |
| 1210.2254S | In distribution | |
| 1209.2155S | In distribution | |
| 1210.1191S | In distribution | |
| 1225.0017S | In distribution | |
| 1210.0152S | In distribution | |
| 1210.2296S | In distribution | |
| 1210.1294S | In distribution | |
| 1212.0715S | Width 34 mm | In distribution |
| 1209.0881S | In distribution | |
| 1209.0243S | In distribution | |
| 1210.1149S | In distribution | |
| 1209.2069S | In distribution | |
| 1210.2152S | In distribution | |
| 1210.0110S | In distribution | |
| 1212.1515S | Width 39 mm | In distribution |
| 1210.2154S | In distribution | |
| 1210.0114S | In distribution | |
| 1225.1008S | In distribution | |
| 1212.0515S | Width 30 mm | In distribution |
| 1225.0115S | In distribution | |
| 1209.0345S | In distribution | |
| 1225.1011S | In distribution | |
| 1209.0981S | In distribution | |
| 1209.0279S | In distribution | |
| 1210.1187S | In distribution | |
| 1212.1217S | Depth 29 mm | In distribution |
| 1209.0225S | In distribution | |
| 1225.0013S | In distribution | |
| 1212.0317S | Height 17 mm | In distribution |
| 1210.2195S | In distribution | |
| 1210.1197S | In distribution | |
| 1209.0361S | In distribution | |
| 1210.1157S | In distribution | |
| 1212.0415S | Angle 25 ° | In distribution |
| 1209.0357S | In distribution | |
| 1209.1001S | In distribution | |
| 1209.0923S | In distribution | |
| 1209.2109S | In distribution | |
| 1209.1047S | In distribution | |
| 1210.1155S | In distribution | |
| 1225.0110S | In distribution | |
| 1212.0821S | Depth 26 mm | In distribution |
| 1210.1290S | In distribution | |
| 1209.0205S | In distribution | |
| 1225.0009S | In distribution | |
| 1225.0008S | In distribution | |
| 1225.1009S | In distribution | |
| 1212.2813S | In distribution | |
| 1209.0937S | In distribution | |
| 1209.0897S | In distribution | |
| 1209.0283S | In distribution | |
| 1210.0155S | In distribution | |
| 1210.2148S | In distribution | |
| 1212.1421S | Angle 25 ° | In distribution |
| 1209.2111S | In distribution | |
| 1209.2135S | In distribution | |
| 1212.0919S | Height 19 mm | In distribution |
| 1210.1196S | In distribution | |
| 7212.0025 | In distribution | |
| 1209.2073S | In distribution | |
| 1210.0157S | In distribution | |
| 1209.0901S | In distribution | |
| 1209.1995S | In distribution | |
| 1209.0983S | In distribution | |
| 1209.0321S | In distribution | |
| 1210.2255S | In distribution | |
| 1209.1013S | In distribution | |
| 1209.1003S | In distribution | |
| 1209.2115S | In distribution | |
| 1209.0301S | In distribution | |
| 1209.0985S | In distribution | |
| 1209.1027S | In distribution | |
| 1210.2295S | In distribution | |
| 1212.0817S | Depth 26 mm | In distribution |
| 7212.1035 | In distribution | |
| 1210.0256S | In distribution | |
| 1212.1315S | Width 39 mm | In distribution |
| 1225.0011S | In distribution | |
| 1225.0113S | In distribution | |
| 1210.2253S | In distribution | |
| 1209.1049S | In distribution | |
| 1210.0215S | In distribution | |
| 1209.0343S | In distribution | |
| 1210.0254S | In distribution | |
| 1209.0919S | In distribution | |
| 6210.0002 | In distribution | |
| 1209.0183S | In distribution | |
| 1209.1053S | In distribution | |
| 1225.0112S | In distribution | |
| 1212.0819S | Height 19 mm | In distribution |
| 1210.0107S | In distribution | |
| 1209.0999S | In distribution | |
| 1209.0961S | In distribution | |
| 1209.0941S | In distribution | |
| 1209.2009S | In distribution | |
| 1212.1213S | Angle 15 ° | In distribution |
| 1212.1119S | Width 39 mm | In distribution |
| 1210.0153S | In distribution | |
| 1209.1055S | In distribution | |
| 1210.2256S | In distribution | |
| 1225.1111S | In distribution | |
| 1210.2196S | In distribution | |
| 1212.1115S | Angle 8 ° | In distribution |
| 1212.1419S | Depth 29 mm | In distribution |
| 1209.1971S | In distribution | |
| 1210.1292S | In distribution | |
| 1209.0965S | In distribution | |
| 1210.1296S | In distribution | |
| 1210.2191S | In distribution | |
| 1212.1221S | Width 39 mm | In distribution |
| 1210.0149S | In distribution | |
| 1209.0263S | In distribution | |
| 1209.2095S | In distribution | |
| 1209.0299S | In distribution | |
| 1210.2192S | In distribution | |
| 1210.0112S | In distribution | |
| 1209.2093S | In distribution | |
| 1209.0197S | In distribution | |
| 1212.0521S | Width 30 mm | In distribution |
| 1212.0117S | Height 17 mm | In distribution |
| 1209.0957S | In distribution | |
| 7212.0020 | In distribution | |
| 1210.0147S | In distribution | |
| 1209.0297S | In distribution | |
| 1210.2151S | In distribution | |
| 1210.1254S | In distribution | |
| 1210.1153S | In distribution | |
| 1209.1975S | In distribution | |
| 1209.2053S | In distribution | |
| 1210.1297S | In distribution | |
| 1210.0210S | In distribution | |
| 1210.2156S | In distribution | |
| 1212.0717S | Angle 15 ° | In distribution |
| 7212.0040 | In distribution | |
| 1209.0939S | In distribution | |
| 1210.1188S | In distribution | |
| 1210.0113S | In distribution | |
| 1209.0181S | In distribution | |
| 1210.2190S | In distribution | |
| 1209.0245S | In distribution | |
| 1210.2297S | In distribution | |
| 1209.1969S | In distribution | |
| 1209.0237S | In distribution | |
| 1209.0185S | In distribution | |
| 1210.2193S | In distribution | |
| 1209.0903S | In distribution | |
| 1209.1033S | In distribution | |
| 1212.0613S | Depth 26 mm | In distribution |
| 1209.0943S | In distribution | |
| 1225.1012S | In distribution | |
| 1209.0323S | In distribution | |
| 1212.1517S | Width 39 mm | In distribution |
| 1210.1189S | In distribution | |
| 1209.0257S | In distribution | |
| 1209.1009S | In distribution | |
| 1210.2294S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234035 | 2024-09-06 |
| K221894 | 2023-08-03 |
| K203278 | 2021-02-02 |
| K192115 | 2020-01-14 |
| K191391 | 2019-09-18 |
| K181357 | 2018-12-06 |
| K171848 | 2017-12-21 |
| K152022 | 2017-02-22 |
| K143578 | 2016-04-13 |
| K151665 | 2016-03-16 |
| K140411 | 2014-07-01 |
| K130478 | 2013-07-26 |
| K123913 | 2013-05-13 |
| K123231 | 2013-01-18 |
| K122097 | 2012-12-06 |
| K113447 | 2012-01-26 |
| K102293 | 2011-01-05 |
| K102313 | 2010-12-03 |
| K093242 | 2009-12-23 |
| K072970 | 2008-01-18 |
Recalls
22 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.