Tornier Perform Humeral System
Fracture Stem Screw
2manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | PAO |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2023-01-04 |
| Record revised | 2025-02-06 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 22 to 210 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PFX00130 | Length 30 mm | In distribution |
| PFX00124 | Length 24 mm | In distribution |
| PFX00126 | Length 26 mm | In distribution |
| PFX09090 | Length 90 mm | In distribution |
| PFX00132 | Length 32 mm | In distribution |
| PFX00122 | Length 22 mm | In distribution |
| DWX2PS | PLUS, SHORT | In distribution |
| PFX09210 | X-LONG | In distribution |
| DWX1PL | Size: 1+ | In distribution |
| PFX08170S | Length 170 mm | In distribution |
| DWX1PS | PLUS, SHORT | In distribution |
| PFX00136 | Length 36 mm | In distribution |
| PFX00128 | Length 28 mm | In distribution |
| DWX3SX | STD, X-LONG | In distribution |
| PFX00134 | Length 34 mm | In distribution |
| DWX912 | Thickness 9 mm | In distribution |
| PFX10170 | Size 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 85 |
| Perform™ Humeral System | Tornier Inc. | 76 |
| Comprehensive® Reverse Shoulder | Biomet Orthopedics | 68 |
| Link Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 64 |
| Anatomical Shoulder™ Domelock® | Zimmer, Inc. | 43 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 38 |
| Link Embrace Shoulder System Line Extension | Waldemar Link GmbH & Co. KG | 32 |
| Inhance | Depuy (Ireland) | 31 |
| Comprehensive Instrumentation | Biomet Orthopedics | 16 |
| Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 13 |
| Maestro™ Total Wrist | Biomet Orthopedics | 13 |
| Comprehensive® | Zimmer, Inc. | 11 |
Showing 12 of 29. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201315 | 2020-09-11 |
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 |
|---|---|---|---|---|
| 2024-08-29 | Class II | Under Investigation by firm | Devices from one lot of Perform” Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer. | 38 units |
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.