Omnifit
10 Degree Series II Insert
9manufacturers in China registered for this device type
48catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K974685 |
| Record published | 2015-09-24 |
| Record revised | 2026-07-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Lumen/inner diameter 22 to 32 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2041C-2256 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2041C-2658 | Lumen/Inner Diameter 26.0 mm | In distribution |
| S-2301C-2850 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2043C-2866 | Lumen/Inner Diameter 28.0 mm | In distribution |
| S-2301C-3270 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041C-2250 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2043C-2650 | Lumen/Inner Diameter 26.0 mm | In distribution |
| S-2302C-2846 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 6070-0525A | Taper Connection: C-TPR | In distribution |
| S-2301C-2866 | Lumen/Inner Diameter 28.0 mm | In distribution |
| S-2302C-2870 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 6076-0625A | Neck Length: 25.0 Millimeter | In distribution |
| 2043C-2858 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 6076-0525A | Taper Connection: C-TPR | In distribution |
| 2043C-2258 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2041C-2258 | Lumen/Inner Diameter 22.0 mm | In distribution |
| S-2301C-2848 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041C-2852 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2043C-2654 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2043C-3262 | Lumen/Inner Diameter 32.0 mm | In distribution |
| S-2301C-3256 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2043C-2262 | Lumen/Inner Diameter 22.0 mm | In distribution |
| S-2301C-2846 | Lumen/Inner Diameter 28.0 mm | In distribution |
| S-2302C-2856 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041C-2854 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041C-2650 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2042C-2652 | Lumen/Inner Diameter 26.0 mm | In distribution |
| S-2301C-2858 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041C-3262 | Lumen/Inner Diameter 32.0 mm | In distribution |
| S-2301C-2862 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041C-2646 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2041C-3266 | Lumen/Inner Diameter 32.0 mm | In distribution |
| S-2302C-2854 | Lumen/Inner Diameter 28.0 mm | In distribution |
| S-2302C-3252 | Lumen/Inner Diameter 32.0 mm | In distribution |
| S-2302C-2866 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 6076-0830A | Taper Connection: C-TPR | In distribution |
| S-2302C-3258 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041C-2862 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2043C-2642 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2041C-2662 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2041C-3258 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2042C-2852 | Lumen/Inner Diameter 28.0 mm | In distribution |
| S-2301C-3266 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041C-2846 | Lumen/Inner Diameter 28.0 mm | In distribution |
| S-2301C-2854 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041C-2642 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2041C-2656 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2043C-2854 | Lumen/Inner Diameter 28.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
| Aesculap | Aesculap AG | 38 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023692 | 2003-03-20 |
| K993601 | 1999-11-16 |
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 |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2019-11-07 | Class II | Employee error | May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire | 20 units | 2020-08-31 |
| Howmedica Osteonics Corp | 510(k) number | 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| 2009-06-18 | Not classified | Process control | Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. | 13 total, both products. | 2012-08-27 |
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.