Healicoil / Ultrabraid
The Healicoil PK Suture Anchor attaches soft tissue to bone during specified orthopedic repairs. It is a screw-in anchor made from PEEK, or polyetheretherketone. The listed configuration…
The Healicoil PK Suture Anchor attaches soft tissue to bone during specified orthopedic repairs. It is a screw-in anchor made from PEEK, or polyetheretherketone. The listed configuration has a 5.5 mm diameter and is supplied preloaded with sutures.
The anchor comes preassembled on a stainless steel inserter for placement. Its open architecture includes spaces between the threads and a central channel. Sutures carried by the anchor provide the means of securing the tissue to the bone fixation point.
Listed Item
Healicoil SA PK 5.5MM W/2 UB-BL Cbrd BL
Repair Applications
Indications include rotator cuff and other shoulder repairs, selected knee ligament and tendon repairs, foot and ankle reconstruction, elbow tendon or ligament repair, and gluteal tendon repair at the hip.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K113294 |
| Record published | 2015-08-29 |
| Record revised | 2023-09-07 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72203379 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261968 | 2026-07-09 |
| K251627 | 2025-06-25 |
| K241435 | 2024-06-20 |
| K233730 | 2024-01-17 |
| K232457 | 2023-09-08 |
| K231376 | 2023-08-09 |
| K232005 | 2023-08-04 |
| K222971 | 2023-02-17 |
| K152566 | 2015-12-02 |
| K140879 | 2014-07-21 |
| K122059 | 2013-03-18 |
| K123425 | 2013-02-20 |
| K123579 | 2013-01-23 |
| K121018 | 2012-06-22 |
| K113274 | 2012-03-06 |
| K112526 | 2012-01-31 |
| K113294 | 2012-01-20 |
| K110545 | 2011-06-24 |
| K093935 | 2010-04-05 |
| K093228 | 2009-12-15 |
| K081511 | 2008-08-26 |
| K061154 | 2006-06-08 |
Recalls
14 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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-10-29 | Class II | Package design/selection | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. | 2,156 units | |
| 2020-06-24 | Class II | Process control | A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill. | 868 | |
| 2020-03-17 | Class II | Package design/selection | Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach. | 125,196 (total) | |
| 2020-03-17 | Class II | Package design/selection | Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach. | 125,196 (Total) | |
| 2019-12-30 | Class II | Package design/selection | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the steril | 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, | 2021-05-11 |
| 2014-06-02 | Class II | Package design/selection | Sterility of device is compromised due to breach in sterile barrier | 907 units | 2017-09-15 |
| 2014-06-02 | Class II | Package design/selection | Sterility of device is compromised due to breach in sterile barrier | 136 units | 2017-09-15 |
| 2014-06-02 | Class II | Package design/selection | Sterility of device is compromised due to breach in sterile barrier | 259 units | 2017-09-15 |
| 2014-06-02 | Class II | Package design/selection | Sterility of device is compromised due to breach in sterile barrier | 1086 untis | 2017-09-15 |
| 2014-06-02 | Class II | Package design/selection | Sterility of device is compromised due to breach in sterile barrier | 763 units | 2017-09-15 |
| 2012-07-03 | Class II | Device Design | Distal part of the anchor may break on insertion into bone during surgery | 2,204 units | 2016-04-18 |
| 2012-07-03 | Class II | Device Design | Distal part of the anchor may break on insertion into bone during surgery | 4,411 units | 2016-04-18 |
| 2012-07-03 | Class II | Device Design | Distal part of the anchor may break on insertion into bone during surgery | 4,661 units | 2016-04-18 |
| 2012-07-03 | Class II | Device Design | Distal part of the anchor may break on insertion into bone during surgery | 913 units | 2016-04-18 |
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.