Signature
Catalogue number SSI004923, listed by Biomet Orthopedics, United States, under Knee Arthroplasty Implantation System. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | OOG |
| Device type | Knee Arthroplasty Implantation System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K102795 |
| Record published | 2018-11-12 |
| Record revised | 2025-05-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSI004923 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 1,463 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 202 |
| iTotal Identity CR | ConforMIS, Inc. | 138 |
| My Knee Femoral Cutting Blocks | Medacta International SA | 60 |
| iTotal® CR iPoly™ Insert Kit | ConforMIS, Inc. | 59 |
| My Knee Tibial Cutting Blocks | Medacta International SA | 48 |
| My Knee Femoral Cutting Blocks MIS | Medacta International SA | 42 |
| My Knee Tibial Cutting Blocks MIS | Medacta International SA | 36 |
| iTotal® Identity Cruciate Retaining Knee Replacement System | ConforMIS, Inc. | 27 |
| iTotal® CR iPoly® XE Insert Kit | ConforMIS, Inc. | 16 |
| Zimmer Patient Specific Instruments | Materialise NV | 12 |
| iTotal Identity CR Knee Replacement System | ConforMIS, Inc. | 12 |
Showing 12 of 95. All products under Knee Arthroplasty Implantation System
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Materialise USA, LLC. | 510(k) number | 2016-05-03 | Class II | Process control | A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient sp | 1 | 2016-06-28 |
| Materialise N.V. | 510(k) number | 2015-02-04 | Class II | Employee error | Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation. | 1 unit | 2015-10-30 |
| Biomet, Inc. | 510(k) number | 2011-08-04 | Not classified | Labeling mix-ups | Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distributor’s office as a product complaint. | 2 units | 2012-09-06 |
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.