Comprehensive® Reverse Shoulder— 510(k) K193373
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K193373 for Comprehensive® Reverse Shoulder, Substantially Equivalent on 2020-04-15. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code PHX
view allMore clearances from Biomet, Inc.
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K193373
K-number listed on FDA's recall record- Z-0619-2021 — Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- Z-0093-2021 — Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193373.
Data sourced from openFDA. This site is unofficial and independent of the FDA.