DEPUY GLOBAL UNITE SHOULDER SYSTEM— 510(k) K101996

Name: FDA 510(k) clearance K101996
Creator: U.S. Food and Drug Administration
Published: 2010-12-15

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K101996 for DEPUY GLOBAL UNITE SHOULDER SYSTEM, Substantially Equivalent on 2010-12-15. Applicant: Depuy(Ireland). Device class: 2.

Clearance details

Applicant: Depuy(Ireland)
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2010-07-15
Decision date: 2010-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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K260556 — Veritas Shoulder System2026-07-01
K261683 — Augment Off-Axis Instrument System2026-06-16
K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12
K261016 — MSS - Humeral reverse liners extension2026-06-10
K253992 — Veritas Reverse Total Shoulder System2026-05-07

More clearances from Depuy(Ireland)

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K212683 — GLOBAL ICON Stemless Shoulder System2022-01-19
K192855 — DELTA XTEND(TM) Reverse Shoulder System2020-02-24
K190344 — DePuy Corail AMT Hip Prosthesis2019-11-01
K191779 — Attune Revision LPS Inserts2019-10-08
K192448 — Delta Xtend Revers Shoulder System2019-10-04

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K101996

K-number listed on FDA's recall record

Z-0483-2022 — GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610Class II·Terminated·DePuy Orthopaedics, Inc.·20211207
Z-0484-2022 — GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100Class II·Terminated·DePuy Orthopaedics, Inc.·20211207
Z-0485-2022 — GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600Class II·Terminated·DePuy Orthopaedics, Inc.·20211207
Z-0486-2022 — GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100Class II·Terminated·DePuy Orthopaedics, Inc.·20211207
Z-0487-2022 — GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600Class II·Terminated·DePuy Orthopaedics, Inc.·20211207
Z-0488-2022 — GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100Class II·Terminated·DePuy Orthopaedics, Inc.·20211207
Z-0489-2022 — GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100Class II·Terminated·DePuy Orthopaedics, Inc.·20211207
Z-0490-2022 — GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100Class II·Terminated·DePuy Orthopaedics, Inc.·20211207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101996.

Data sourced from openFDA. This site is unofficial and independent of the FDA.