Twinfix
The TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 and Needles, SL is a soft-tissue fixation device. The FDA filing describes the anchor as designed to reattach soft tissue to…
The TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 and Needles, SL is a soft-tissue fixation device. The FDA filing describes the anchor as designed to reattach soft tissue to bone.
The named configuration includes a titanium-alloy anchor, non-absorbable sutures and attached stainless-steel needles. Its listed uses include fixation of synthetic surgical suture material for the shoulder and other anatomical sites.
Listed Item
TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES WITH NEEDLES ONE ULTRABRAID WHITE SUTURE AND ONE ULTRABRAID COBRAID SUTURE, STERILE
Listed Uses
The filing lists shoulder procedures including Bankart lesion, SLAP lesion and rotator cuff repairs. It also lists selected foot, ankle, elbow, wrist, hand and knee procedures.
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) | K123425 |
| Record published | 2015-08-29 |
| Record revised | 2025-07-07 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 3 |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72202898 | In distribution | |
| 72203787 | In distribution | |
| 72202626 | In distribution | |
| 7210707 | In distribution | |
| 72202622 | In distribution | |
| 72200769 | In distribution | |
| 7209109 | In distribution | |
| 72202623 | In distribution | |
| 7210708 | In distribution | |
| 72202900 | In distribution | |
| 72200763 | In distribution | |
| 72200750 | In distribution | |
| 7210302 | In distribution | |
| 72202067 | In distribution | |
| 72202605 | In distribution | |
| 72202894 | In distribution | |
| 7209108 | In distribution | |
| 72202899 | In distribution | |
| 72202599 | In distribution | |
| 7210301 | In distribution | |
| 72202606 | In distribution | |
| 72200796 | In distribution | |
| 7209107 | In distribution | |
| 72202595 | In distribution | |
| 72202600 | In distribution | |
| 72203784 | In distribution | |
| 72202615 | In distribution | |
| 72202893 | In distribution | |
| 72202611 | In distribution | |
| 72202895 | In distribution | |
| 72202896 | In distribution | |
| 72202613 | In distribution | |
| 72202630 | In distribution | |
| 72202897 | In distribution | |
| 72202625 | In distribution | |
| 72202619 | In distribution | |
| 72203105 | In distribution | |
| 72202618 | In distribution | |
| 7210709 | In distribution | |
| 72200755 | In distribution | |
| 72200687 | Withdrawn | |
| 72200686 | Withdrawn | |
| 72200768 | Withdrawn | |
| 7209105 | Withdrawn | |
| 7210292 | Withdrawn |
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 Naming This Product
2 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 | 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 | |
| Smith & Nephew, Inc. | 510(k) number | 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 |
Recalls
12 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 |
|---|---|---|---|---|---|
| 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) | |
| 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.