10 X 28mm Citrelock ACL Implant
The Citrelock ACL Implant fixes ligament or tendon graft tissue to bone, including during anterior cruciate ligament repair. The listed implant measures 10 mm in diameter and 28 mm long. It…
The Citrelock ACL Implant fixes ligament or tendon graft tissue to bone, including during anterior cruciate ligament repair. The listed implant measures 10 mm in diameter and 28 mm long. It uses an interference fixation design placed into a surgically prepared bone site.
The implant has a twist-ribbed, self-locking shape with a central cannula for alignment during insertion. It is made from Citregen, a biocomposite containing 60% unsintered hydroxyapatite and 40% polyester by weight. The citrate-based polymer forms a crosslinked network.
Material and Placement
The material is resorbed over time as water causes hydrolysis of the polymer. The implant is supplied sterile, and placement uses a compatible reusable instrument set.
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Acuitive Technologies, United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K210239 |
| Record published | 2023-06-23 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-103-1033 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221468 | 2023-02-14 |
| K220833 | 2022-11-04 |
| K210239 | 2021-02-24 |
| K203334 | 2021-02-05 |
| K200725 | 2020-10-07 |
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.