FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tornier Perform Humeral System Fracture
K Number: K220914
·
Decision Oct 14, 2022
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
51
Review Days
198
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Tornier Perform Humeral System Fracture
- K Number
- K220914
- 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
- March 30, 2022
- Decision Date
- October 14, 2022
- Product Code
- PHX
- 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 |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHX), ordered by most recent decision date.
Augment Off-Axis Instrument System
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
MSS - Humeral reverse liners extension
FDA 510(k)
FDA Class 2
·Orthopedic
Veritas Reverse Total Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
FDA 510(k)
FDA Class 2
·Orthopedic
Equinoxe® Shoulder System
FDA 510(k)
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 |
| 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 |