RSP HUMERAL SOCKET INSERT— 510(k) K141006

Name: FDA 510(k) clearance K141006
Creator: U.S. Food and Drug Administration
Published: 2014-06-05

Substantially Equivalent

Djo Global

FDA 510(k) clearance K141006 for RSP HUMERAL SOCKET INSERT, Substantially Equivalent on 2014-06-05. Applicant: Djo Global. Device class: 2.

Clearance details

Applicant: Djo Global
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2014-04-18
Decision date: 2014-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

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

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 K141006

K-number listed on FDA's recall record

Z-3021-2020 — RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044Class II·Ongoing·Encore Medical, LP·20200807
Z-3022-2020 — RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440Class II·Ongoing·Encore Medical, LP·20200807

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141006.

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