FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFORM Humeral System Stem
K Number: K201315
·
Decision Sep 11, 2020
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
0
Applicant Total
51
Review Days
116
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Basic Information
- Device Name
- PERFORM Humeral System Stem
- K Number
- K201315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tornier, Inc.
- Date Received
- May 18, 2020
- Decision Date
- September 11, 2020
- Product Code
- PAO
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | FDA class 2 | Orthopedic |
Other Clearances by Tornier, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | Jan 8, 2026 | Substantially Equivalent |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Oct 30, 2025 | Substantially Equivalent |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | Oct 31, 2023 | Substantially Equivalent |
| K220914 | Tornier Perform Humeral System Fracture | Oct 14, 2022 | Substantially Equivalent |
| K220418 | Tornier Perform Humeral System Stemless | Sep 14, 2022 | Substantially Equivalent |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | Nov 12, 2021 | Substantially Equivalent |
| K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres | Oct 26, 2021 | Substantially Equivalent |
| K193247 | LATITUDE EV Total Elbow Arthroplasty | Aug 5, 2020 | Substantially Equivalent |
| K191711 | ORTHOLOC SPS Shoulder Plating System | Jul 17, 2019 | Substantially Equivalent |
| K191318 | AEQUALIS FLEX REVIVE Shoulder System | Jun 14, 2019 | Substantially Equivalent |