Home / 510(k) Clearances / K190834

510(k) K190834

Corin Optimized Position System Functional Hip Analysis (OPS FHA) by Corin USA — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2019
Date Received
April 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Corin USA

  • K203751 — OMNIVision system (April 12, 2021)
  • K202805 — Optimized Positioning System (OPS) Insight (November 20, 2020)
  • K193545 — Corin Optimized Positioning System (OPS) Femoral (August 4, 2020)
  • K193042 — Optimized Positioning System (OPS) ReView (June 26, 2020)
  • K192656 — Optimized Positioning System (OPS) Insight (May 1, 2020)
  • K190143 — LARS AC Band Device (November 4, 2019)
  • K183038 — Corin Optimized Positioning System (OPS) Plan (November 26, 2018)
  • K181061 — Corin Optimized Positioning System (OPS) Femoral (September 7, 2018)
  • K152893 — Corin Optimized Positioning System (OPS) (June 3, 2016)
  • K152903 — REVIVAL(TM) Modular Revision Hip Stem (April 29, 2016)

Other clearances for product code LZO

  • K252401 — implaFit® short stems (March 12, 2026)
  • K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (January 15, 2026)
  • K250450 — Coated hip implants (September 19, 2025)
  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
  • K243927 — MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)