Acumed
ARH Slide-Loc™ Trial Long Stem 10mm, RT
3manufacturers in China registered for this device type
175catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Acumed LLC, United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K041858 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2016-03-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50-0056-S | In distribution | |
| 5001-0109N-S | In distribution | |
| 5101-0224L | In distribution | |
| 50-0059-S | In distribution | |
| TR-S0802-S | In distribution | |
| 5001-0518L-S | In distribution | |
| 50-0109-S | In distribution | |
| 50-0079-S | In distribution | |
| 5101-0224R | In distribution | |
| 5001-0522R-S | In distribution | |
| 5101-0108N | In distribution | |
| 50-0064-S | In distribution | |
| 5101-0105N | In distribution | |
| 5001-0520R-S | In distribution | |
| 5101-0106N | In distribution | |
| TR-S1108-S | In distribution | |
| 50-0061-S | In distribution | |
| TR-S0600-S | In distribution | |
| TR-H240R-S | In distribution | |
| 5101-0406R | In distribution | |
| TR-S0908-S | In distribution | |
| 5001-0528L-S | In distribution | |
| 5101-0222R | In distribution | |
| TR-S1204-S | In distribution | |
| 5001-0230L-S | In distribution | |
| 50-0116-S | In distribution | |
| 50-0063-S | In distribution | |
| TR-S0806-S | In distribution | |
| 50-0067-S | In distribution | |
| 5001-0220L-S | In distribution | |
| TR-S0604-S | In distribution | |
| TR-SL11-S | In distribution | |
| TR-SL09-S | In distribution | |
| 5101-0305N | In distribution | |
| 5101-0410R | In distribution | |
| 5001-0224L-S | In distribution | |
| 50-0069-S | In distribution | |
| 5101-0226R | In distribution | |
| 5101-0226L | In distribution | |
| TR-SL06-S | In distribution | |
| 5001-0108N-S | In distribution | |
| 5101-0109N | In distribution | |
| 5101-0408R | In distribution | |
| 50-0068-S | In distribution | |
| 5101-0218L | In distribution | |
| 80-2544 | In distribution | |
| TR-SL08-S | In distribution | |
| 5001-0106N-S | In distribution | |
| 5101-0410L | In distribution | |
| TR-S0708-S | In distribution | |
| TR-S1004-S | In distribution | |
| TR-S0904-S | In distribution | |
| 5001-0218R-S | In distribution | |
| 50-0113-S | In distribution | |
| 5101-0220L | In distribution | |
| 5101-0228L | In distribution | |
| 5101-0220R | In distribution | |
| 50-0062-S | In distribution | |
| TR-H260L-S | In distribution | |
| TR-SL07-S | In distribution | |
| TR-S1208-S | In distribution | |
| 5001-0220R-S | In distribution | |
| 5001-0412R-S | In distribution | |
| TR-SL10-S | In distribution | |
| 5101-0222L | In distribution | |
| 5001-0218L-S | In distribution | |
| 50-0058-S | In distribution | |
| 5001-0228L-S | In distribution | |
| 50-0114-S | In distribution | |
| 5001-0305N-S | In distribution | |
| TR-S0706-S | In distribution | |
| TR-S1206-S | In distribution | |
| TR-H280R-S | In distribution | |
| 50-0118-S | In distribution | |
| 5001-0406L-S | In distribution | |
| 5001-0301N-S | In distribution | |
| 50-0073-S | In distribution | |
| TR-S0606-S | In distribution | |
| TR-S0700-S | In distribution | |
| 50-0060-S | In distribution | |
| 5001-0111N-S | In distribution | |
| TR-SL12-S | In distribution | |
| 80-2547 | In distribution | |
| 5101-0111N | In distribution | |
| 5001-0408L-S | In distribution | |
| TR-S1202-S | In distribution | |
| 5001-0112N-S | In distribution | |
| 50-0077-S | In distribution | |
| TR-S0902-S | In distribution | |
| TR-S1102-S | In distribution | |
| TR-H200R-S | In distribution | |
| 5101-0412L | In distribution | |
| TR-H200L-S | In distribution | |
| 5001-0526L-S | In distribution | |
| 5001-0303N-S | In distribution | |
| TR-S0804-S | In distribution | |
| TR-S0906-S | In distribution | |
| TR-S0808-S | In distribution | |
| TR-S1200-S | In distribution | |
| 5001-0520L-S | In distribution | |
| 5001-0518R-S | In distribution | |
| TR-S1000-S | In distribution | |
| 5001-0230R-S | In distribution | |
| 5101-0412R | In distribution | |
| 5001-0224R-S | In distribution | |
| 5001-0107N-S | In distribution | |
| 5101-0303N | In distribution | |
| TR-S0900-S | In distribution | |
| 5001-0524R-S | In distribution | |
| 5101-0230R | In distribution | |
| 50-0112-S | In distribution | |
| 5001-0408R-S | In distribution | |
| TR-S0704-S | In distribution | |
| TR-S1008-S | In distribution | |
| 5001-0226R-S | In distribution | |
| 5001-0406R-S | In distribution | |
| 5001-0228R-S | In distribution | |
| 5101-0301N | In distribution | |
| 50-0117-S | In distribution | |
| 50-0065-S | In distribution | |
| 50-0111-S | In distribution | |
| TR-S1104-S | In distribution | |
| 50-0070-S | In distribution | |
| 5001-0222L-S | In distribution | |
| 5001-0105N-S | In distribution | |
| 5001-0110N-S | In distribution | |
| 5101-0107N | In distribution | |
| 50-0074-S | In distribution | |
| TR-H220L-S | In distribution | |
| 80-2543 | In distribution | |
| 5001-0222R-S | In distribution | |
| 50-0066-S | In distribution | |
| 50-0115-S | In distribution | |
| 5001-0410L-S | In distribution | |
| 5001-0412L-S | In distribution | |
| 80-2546 | In distribution | |
| TR-S0602-S | In distribution | |
| 5101-0408L | In distribution | |
| 5001-0226L-S | In distribution | |
| TR-H240L-S | In distribution | |
| TR-S1100-S | In distribution | |
| 5101-0228R | In distribution | |
| 5101-0112N | In distribution | |
| 50-0072-S | In distribution | |
| TR-TGA06 | In distribution | |
| 50-0071-S | In distribution | |
| TR-S1106-S | In distribution | |
| TR-S0800-S | In distribution | |
| 50-0080-S | In distribution | |
| TR-H280L-S | In distribution | |
| TR-H260R-S | In distribution | |
| 5101-0406L | In distribution | |
| 5001-0528R-S | In distribution | |
| 5001-0410R-S | In distribution | |
| TR-H220R-S | In distribution | |
| 5001-0526R-S | In distribution | |
| TR-S1002-S | In distribution | |
| 80-2545 | In distribution | |
| 80-2542 | In distribution | |
| 5001-0522L-S | In distribution | |
| 5101-0110N | In distribution | |
| TR-S0608-S | In distribution | |
| 50-0110-S | In distribution | |
| 5001-0524L-S | In distribution | |
| 50-0076-S | In distribution | |
| TR-S1006-S | In distribution | |
| TR-S0702-S | In distribution | |
| 50-0078-S | In distribution | |
| 50-0075-S | In distribution | |
| 5101-0218R | In distribution | |
| 5101-0230L | In distribution | |
| 50-0057-S | In distribution | |
| 80-1727 | Withdrawn | |
| 80-1724 | Withdrawn | |
| 80-1723 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| Rhead | Stryker GmbH | 53 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131845 | 2013-09-30 |
| K041858 | 2004-10-05 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2017-04-20 | Class II | Under Investigation by firm | The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product des | 13076 parts total (8373 units of parts/instruments and 4703 | 2017-12-01 |
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.