OrthoSolutions 'System26' Bone Screws— 510(k) K163489

Name: FDA 510(k) clearance K163489
Creator: U.S. Food and Drug Administration
Published: 2017-03-08

Substantially Equivalent

Ortho Solutions UK Limited

FDA 510(k) clearance K163489 for OrthoSolutions 'System26' Bone Screws, Substantially Equivalent on 2017-03-08. Applicant: Ortho Solutions UK Limited. Device class: 2.

Clearance details

Applicant: Ortho Solutions UK Limited
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2016-12-12
Decision date: 2017-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maldon, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

view all

K261057 — ActivaScrew Cannulated COM2026-09-04
K260106 — OsteoCoil GT Active Compression System2026-08-24
K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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 K163489

K-number listed on FDA's recall record

Z-0967-2018 — SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS; OS900057-NS.Class II·Terminated·ORTHO SOLUTIONS, LTD.·20171010

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163489.

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