FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
K Number: K251686
·
Decision Oct 30, 2025
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
51
Review Days
150
Basic Information
- Device Name
- Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- K Number
- K251686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tornier, Inc.
- Date Received
- June 2, 2025
- Decision Date
- October 30, 2025
- Product Code
- KWT
- 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 |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Tornier, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | Jan 8, 2026 | 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 |
| K201315 | PERFORM Humeral System Stem | Sep 11, 2020 | 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 |