GLOBAL UNITE Platform Shoulder System— 510(k) K170748

Name: FDA 510(k) clearance K170748
Creator: U.S. Food and Drug Administration
Published: 2018-01-11

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K170748 for GLOBAL UNITE Platform Shoulder System, Substantially Equivalent on 2018-01-11. Applicant: Depuy Ireland UC. Device class: 2.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2017-03-10
Decision date: 2018-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, 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 UC

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K260480 — VELYS Robotic-Assisted Solution2026-06-25
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
K253624 — INHANCE Reverse Shoulder System2026-03-11
K253551 — VELYS Hip Navigation2026-03-06

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 K170748

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 K170748.

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