Surfix
The SURFIX Knee Osteotomy System consists of different stainless steel plates for the proximal tibia and the distal femur with a locking system between the threaded sockets of the plates…
The SURFIX Knee Osteotomy System consists of different stainless steel plates for the proximal tibia and the distal femur with a locking system between the threaded sockets of the plates and the lock screws. Their fixation is provided by titanium alloy screws and lock screws available in two versions : cancellous bone screws diameter 6.5 mm and cortical bone screws diameter 4.5 mm. The system fixation creates a single implant/screw unit fixed into the bone thanks to the lock screw.
22manufacturers in China registered for this device type
171catalogue numbers in this listing
7510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Newdeal Sas, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K070160 |
| Record published | 2017-10-09 |
| Record revised | 2025-11-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 286422SND | 4.5mm diam. x 22mm length | In distribution |
| SP025ND | 6.5mm diam. x 25mm length | In distribution |
| 285336SND | 3.5mm diam. x 36mm length | In distribution |
| 285338SND | 3.5mm diam. x 38mm length | In distribution |
| CC022ND | 4.5mm diam. x 22mm length | In distribution |
| SP020ND | 6.5mm diam. x 20mm length | In distribution |
| 285645SND | 6.5mm diam. x 45mm length | In distribution |
| CC028ND | 4.5mm diam. x 28mm length | In distribution |
| SP085ND | 6.5mm diam. x 85mm length | In distribution |
| 286222ND | 2.7mm diam. x 22mm length | In distribution |
| 286420SND | 4.5mm diam. x 20mm length | In distribution |
| 286216ND | 2.7mm diam. x 16mm length | In distribution |
| 286455SND | 4.5mm diam. x 55mm length | In distribution |
| 286324ND | 3.5mm diam. x 24mm length | In distribution |
| SP065ND | 6.5mm diam. x 65mm length | In distribution |
| 285450SND | 4.5mm diam. x 50mm length | In distribution |
| 285460SND | 4.5mm diam. x 60mm length | In distribution |
| 286332ND | 3.5mm diam. x 32mm length | In distribution |
| CC045ND | 4.5mm diam. x 45mm length | In distribution |
| CC032ND | 4.5mm diam. x 32mm length | In distribution |
| 186300SND | 3.5mm diam. | In distribution |
| CC016ND | 4.5mm diam. x 16mm length | In distribution |
| CC030ND | 4.5mm diam. x 30mm length | In distribution |
| 286334ND | 3.5mm diam. x 34mm length | In distribution |
| 285334ND | 3.5mm diam. x 34mm length | In distribution |
| 285330SND | 3.5mm diam. x 30mm length | In distribution |
| SP070ND | 6.5mm diam. x 70mm length | In distribution |
| PTODND | In distribution | |
| 285326ND | 3.5mm diam. x 26mm length | In distribution |
| POFND | In distribution | |
| 286450SND | 4.5mm diam. x 50mm length | In distribution |
| 285655SND | 6.5mm diam. x 55mm length | In distribution |
| 286332SND | 3.5mm diam. x 32mm length | In distribution |
| CC014ND | 4.5mm diam. x 14mm length | In distribution |
| 285416SND | 4.5mm diam. x 16mm length | In distribution |
| 286655SND | 6.5mm diam. x 55mm length | In distribution |
| CC040ND | 4.5mm diam. x 40mm length | In distribution |
| SP030ND | 6.5mm diam. x 30mm length | In distribution |
| 285635SND | 6.5mm diam. x 35mm length | In distribution |
| 186600SND | 6.5mm diam. | In distribution |
| 286670SND | 6.5mm diam. x 70mm length | In distribution |
| 286675SND | 6.5mm diam. x 75mm length | In distribution |
| 285312SND | 3.5mm diam. x 12mm length | In distribution |
| 286418SND | 4.5mm diam. x 18mm length | In distribution |
| 285320SND | 3.5mm diam. x 20mm length | In distribution |
| 285322SND | 3.5mm diam. x 22mm length | In distribution |
| 286330SND | 3.5mm diam. x 30mm length | In distribution |
| 285426SND | 4.5mm diam. x 26mm length | In distribution |
| 285422SND | 4.5mm diam. x 22mm length | In distribution |
| 285465SND | 4.5mm diam. x 65mm length | In distribution |
| 286218ND | 2.7mm diam. x 18mm length | In distribution |
| 285435SND | 4.5mm diam. x 35mm length | In distribution |
| 285630SND | 6.5mm diam. x 30mm length | In distribution |
| 285660SND | 6.5mm diam. x 60mm length | In distribution |
| 286428SND | 4.5mm diam. x 28mm length | In distribution |
| 285318SND | 3.5mm diam. x 18mm length | In distribution |
| 286326SND | 3.5mm diam. x 26mm length | In distribution |
| 285332ND | 3.5mm diam. x 32mm length | In distribution |
| 285328ND | 3.5mm diam. x 28mm length | In distribution |
| 286210ND | 2.7mm diam. x 10mm length | In distribution |
| 286310SND | 3.5mm diam. x 10mm length | In distribution |
| 286424SND | 4.5mm diam. x 24mm length | In distribution |
| CC065ND | 4.5mm diam. x 65mm length | In distribution |
| 285316ND | 3.5mm diam. x 16mm length | In distribution |
| 285340SND | 3.5mm diam. x 40mm length | In distribution |
| 286314SND | 3.5mm diam. x 14mm length | In distribution |
| PTOGND | In distribution | |
| 285418SND | 4.5mm diam. x 18mm length | In distribution |
| 286320SND | 3.5mm diam. x 20mm length | In distribution |
| 285326SND | 3.5mm diam. x 26mm length | In distribution |
| PTCDND | In distribution | |
| 286334SND | 3.5mm diam. x 34mm length | In distribution |
| 286650SND | 6.5mm diam. x 50mm length | In distribution |
| 286465SND | 4.5mm diam. x 65mm length | In distribution |
| 286310ND | 3.5mm diam. x 10mm length | In distribution |
| 286426SND | 4.5mm diam. x 26mm length | In distribution |
| SP095ND | 6.5mm diam. x 95mm length | In distribution |
| 285330ND | 3.5mm diam. x 30mm length | In distribution |
| 286690SND | 6.5mm diam. x 90mm length | In distribution |
| 286312SND | 3.5mm diam. x 12mm length | In distribution |
| 285316SND | 3.5mm diam. x 16mm length | In distribution |
| SP080ND | 6.5mm diam. x 80mm length | In distribution |
| 285320ND | 3.5mm diam. x 20mm length | In distribution |
| PTFGND | In distribution | |
| 286695SND | 6.5mm diam. x 95mm length | In distribution |
| 285310ND | 3.5mm diam. x 10mm length | In distribution |
| 286620SND | 6.5mm diam. x 20mm length | In distribution |
| CC024ND | 4.5mm diam. x 24mm length | In distribution |
| 286660SND | 6.5mm diam. x 60mm length | In distribution |
| 286435SND | 4.5mm diam. x 35mm length | In distribution |
| 185300SND | 3.5mm diam. | In distribution |
| 285328SND | 3.5mm diam. x 28mm length | In distribution |
| 285314ND | 3.5mm diam. x 14mm length | In distribution |
| 286665SND | 6.5mm diam. x 65mm length | In distribution |
| 286640SND | 6.5mm diam. x 40mm length | In distribution |
| 286680SND | 6.5mm diam. x 80mm length | In distribution |
| 285640SND | 6.5mm diam. x 40mm length | In distribution |
| 286416SND | 4.5mm diam. x 16mm length | In distribution |
| 286414SND | 4.5mm diam. x 14mm length | In distribution |
| 285440SND | 4.5mm diam. x 40mm length | In distribution |
| 286214ND | 2.7mm diam. x 14mm length | In distribution |
| 285310SND | 3.5mm diam. x 10mm length | In distribution |
| 286316SND | 3.5mm diam. x 16mm length | In distribution |
| SP100ND | 6.5mm diam. x 100mm length | In distribution |
| CC035ND | 4.5mm diam. x 35mm length | In distribution |
| 285350SND | 3.5mm diam. x 50mm length | In distribution |
| 185600SND | 6.5mm diam. | In distribution |
| 286318SND | 3.5mm diam. x 18mm length | In distribution |
| 285314SND | 3.5mm diam. x 14mm length | In distribution |
| 286322SND | 3.5mm diam. x 22mm length | In distribution |
| 285334SND | 3.5mm diam. x 34mm length | In distribution |
| 285455SND | 4.5mm diam. x 55mm length | In distribution |
| SP045ND | 6.5mm diam. x 45mm length | In distribution |
| 285332SND | 3.5mm diam. x 32mm length | In distribution |
| 286645SND | 6.5mm diam. x 45mm length | In distribution |
| CC050ND | 4.5mm diam. x 50mm length | In distribution |
| CC018ND | 4.5mm diam. x 18mm length | In distribution |
| 285650SND | 6.5mm diam. x 50mm length | In distribution |
| 286312ND | 3.5mm diam. x 12mm length | In distribution |
| SP060ND | 6.5mm diam. x 60mm length | In distribution |
| 285318ND | 3.5mm diam. x 18mm length | In distribution |
| 286314ND | 3.5mm diam. x 14mm length | In distribution |
| 285324SND | 3.5mm diam. x 24mm length | In distribution |
| 286630SND | 6.5mm diam. x 30mm length | In distribution |
| 285322ND | 3.5mm diam. x 22mm length | In distribution |
| 285414SND | 4.5mm diam. x 14mm length | In distribution |
| 286460SND | 4.5mm diam. x 60mm length | In distribution |
| CC055ND | 4.5mm diam. x 55mm length | In distribution |
| 285445SND | 4.5mm diam. x 45mm length | In distribution |
| 286324SND | 3.5mm diam. x 24mm length | In distribution |
| CC020ND | 4.5mm diam. x 20mm length | In distribution |
| PTCGND | In distribution | |
| 285420SND | 4.5mm diam. x 20mm length | In distribution |
| PTFDND | In distribution | |
| 286635SND | 6.5mm diam. x 35mm length | In distribution |
| SP035ND | 6.5mm diam. x 35mm length | In distribution |
| 286430SND | 4.5mm diam. x 30mm length | In distribution |
| 285625SND | 6.5mm diam. x 25mm length | In distribution |
| 285348SND | 3.5mm diam. x 48mm length | In distribution |
| 285430SND | 4.5mm diam. x 30mm length | In distribution |
| 286685SND | 6.5mm diam. x 85mm length | In distribution |
| 286330ND | 3.5mm diam. x 30mm length | In distribution |
| 185400SND | 4.5mm diam. | In distribution |
| 285312ND | 3.5mm diam. x 12mm length | In distribution |
| 285324ND | 3.5mm diam. x 24mm length | In distribution |
| 185300ND | 3.5mm diam. | In distribution |
| CC060ND | 4.5mm diam. x 60mm length | In distribution |
| 285344SND | 3.5mm diam. x 44mm length | In distribution |
| 286316ND | 3.5mm diam. x 16mm length | In distribution |
| SP090ND | 6.5mm diam. x 90mm length | In distribution |
| 285428SND | 4.5mm diam. x 28mm length | In distribution |
| 286625SND | 6.5mm diam. x 25mm length | In distribution |
| SP075ND | 6.5mm diam. x 75mm length | In distribution |
| 286445SND | 4.5mm diam. x 45mm length | In distribution |
| CC026ND | 4.5mm diam. x 26mm length | In distribution |
| 286700SND | 6.5mm diam. x 100mm length | In distribution |
| 286328SND | 3.5mm diam. x 28mm length | In distribution |
| 285620SND | 6.5mm diam. x 20mm length | In distribution |
| 285424SND | 4.5mm diam. x 24mm length | In distribution |
| 286440SND | 4.5mm diam. x 40mm length | In distribution |
| 285665SND | 6.5mm diam. x 65mm length | In distribution |
| 186400SND | 4.5mm diam. | In distribution |
| SP040ND | 6.5mm diam. x 40mm length | In distribution |
| SP050ND | 6.5mm diam. x 50mm length | In distribution |
| SP055ND | 6.5mm diam. x 55mm length | In distribution |
| 286340SND | 3.5mm diam. x 40mm length | Withdrawn |
| 286338ND | 3.5mm diam. x 38mm length | Withdrawn |
| 286338SND | 3.5mm diam. x 38mm length | Withdrawn |
| 286336ND | 3.5mm diam. x 36mm length | Withdrawn |
| 286336SND | 3.5mm diam. x 36mm length | Withdrawn |
| 286340ND | 3.5mm diam. x 40mm length | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093914 | 2011-04-14 |
| K093781 | 2010-01-22 |
| K083154 | 2009-07-10 |
| K091609 | 2009-06-30 |
| K073375 | 2008-02-21 |
| K070447 | 2007-03-29 |
| K063831 | 2007-02-07 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2022-01-04 | Class II | Process control | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | 8 units (US) | |
| Newdeal Sas | 510(k) number | 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 | |
| Newdeal Sas | 510(k) number | 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 | |
| Newdeal Sas | 510(k) number | 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 | |
| Newdeal Sas | 510(k) number | 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 | |
| Newdeal Sas | 510(k) number | 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 | |
| Integra Lifesciences Corporation | 510(k) number | 2012-02-09 | Class II | Labeling design | Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery. | 2,437 units | 2013-02-19 |
| Integra Lifesciences Corporation | 510(k) number | 2010-11-18 | Not classified | Other | Integra LifeSciences Corporation has decided to initiate a voluntary recall of the Uni-Comp Kits due to inaccurate information relative to the recommended sterilization parameters described in the products Instructions for Use (IFU). The s | Sixty seven (67) Kits | 2011-11-18 |
| Integra Lifesciences Corporation | 510(k) number | 2008-09-30 | Not classified | Nonconforming Material/Component | Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate | 90 | 2009-05-11 |
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.