Restoration
29 catalogue numbers from 1235-2-501, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
29catalogue numbers in this listing
1510(k) clearance
19recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), 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 |
|---|---|---|---|---|
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | MAY |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2026-01-29 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 50 to 58 mm; lumen/inner diameter 28 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1235-2-501 | Side: RIGHT | In distribution |
| 1235-2-581 | Side: RIGHT | In distribution |
| 6276-8-413 | Distal Diameter: 13.0 Millimeter | In distribution |
| 6276-1-127 | Diameter: 27.0 Millimeter | In distribution |
| 6276-1-329 | Diameter: 29.0 Millimeter | In distribution |
| 6276-7-218 | Distal Diameter: 18.0 Millimeter | In distribution |
| 6276-5-016 | Stem Length: 127.0 Millimeter | In distribution |
| 6276-7-225 | Distal Diameter: 25.0 Millimeter | In distribution |
| 6260-6-719 | Distal Diameter: 19.0 Millimeter | In distribution |
| 6276-2-025 | Diameter: 25.0 Millimeter | In distribution |
| 6276-6-216 | Stem Length: 167.0 Millimeter | In distribution |
| 6276-6-220 | Distal Diameter: 20.0 Millimeter | In distribution |
| 6276-6-222 | Distal Diameter: 22.0 Millimeter | In distribution |
| 6276-7-025 | Stem Length: 155.0 Millimeter | In distribution |
| 6276-8-419 | Stem Length: 217.0 Millimeter | In distribution |
| 6276-6-015 | Distal Diameter: 15.0 Millimeter | In distribution |
| 6276-8-522 | Stem Length: 267.0 Millimeter | In distribution |
| 6276-8-417 | Distal Diameter: 17.0 Millimeter | In distribution |
| 6276-7-322 | Distal Diameter: 22.0 Millimeter | In distribution |
| 6276-5-518 | Distal Diameter: 18.0 Millimeter | In distribution |
| 6276-8-526 | Distal Diameter: 26.0 Millimeter | In distribution |
| 6276-6-016 | Distal Diameter: 16.0 Millimeter | In distribution |
| 6276-1-131 | Body Height: 10.0 Millimeter | In distribution |
| 6260-8-616 | Size: 6 | In distribution |
| 6276-7-022 | Distal Diameter: 22.0 Millimeter | In distribution |
| 1235-2-864 | Outer Diameter 58.0 mm | In distribution |
| 6276-7-316 | Stem Length: 235.0 Millimeter | In distribution |
| 6276-5-219 | Stem Length: 167.0 Millimeter | In distribution |
| 6276-7-227 | Stem Length: 195.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument | Howmedica Osteonics Corp | 136 |
| Arcos Modular Revision System | Biomet Orthopedics | 48 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 40 |
| Ringloc HIP System | Biomet Orthopedics | 36 |
| Arcos | Biomet Orthopedics | 19 |
| Echo® Bi-Metric® Hip System | Biomet Orthopedics | 18 |
| Trident | Howmedica Osteonics Corp | 12 |
| Arcos® STS™ Modular Revision System | Biomet Orthopedics | 10 |
| Ringloc Ranawat / Burstein HIP System | Biomet Orthopedics | 10 |
| OrthoMedFlex | Orthomedflex LLC | 10 |
| Taperloc Complete Rasp/Provisional | Biomet Orthopedics | 9 |
| Regenerex® Ringloc®+ Hip System | Biomet Orthopedics | 9 |
Showing 12 of 40. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123604 | 2013-08-16 |
Recalls
15 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 |
|---|---|---|---|---|---|
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 8487 units | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 71 units. | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 207 units | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 1936 units | 2006-04-05 |
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.