510(k) Report

FDA applicant

Plus Orthopedics

San Diego, CA43 decisions1997–200721 recalls

FDA records 43 decisions for Plus Orthopedics (San Diego, CA) from 1997 to 2007: 43 510(k) clearances. Most are in product codes LWJ (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 62 predicates, 24 of them its own earlier devices. 21 recalls are linked to its devices.

FDA’s records also spell it “Plus Orthopedics AG”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Plus Orthopedics’s devices, and how often a recall has named them.

FDA decisions per year

4in 2007

2007: 4
2007high 4 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2010

2010: 4
2007high 4 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Plus Orthopedics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Plus Orthopedics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented7decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…6decisions
  • KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer4decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component3decisions

Also: HAW (3), HSD (2), LPH (2), HRY (2), KWY (1), HWC (1).

Whose devices does it build on?

Its devices cite 62 predicates; 24 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 113 times; 24 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K001942SL-Plus and SLR-Plus StemsPlus Orthopedics · 20009cite it
  • K070278Polarcup Dual Mobility SystemPlus Orthopedics AG · 20078cite it
  • K063578Promos Modular Shoulder SystemPlus Orthopedics AG · 20076cite it
  • K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 20066cite it
  • K982447Plus Bipolar Prosthesis CocrmoPlus Orthopedics · 19985cite it
  • K032126Promos ShoulderPlus Orthopedics · 20045cite it

What has FDA decided for it lately?

  • K070928Ceramic Ball Heads, 28, 32 and 36 MMPlus Orthopedics AG · 2007
  • K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
  • K070278Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
  • K063578Promos Modular Shoulder SystemPlus Orthopedics AG · 20074 recalls
  • K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
  • K032126Promos ShoulderPlus Orthopedics · 2004
  • K033763Modification to Slim Gliding Nail SystemPlus Orthopedics · 2003
  • K032709Modular Plus Hip StemPlus Orthopedics · 2003

All 38 as Plus Orthopedics →All 5 as Plus Orthopedics AG →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K063578PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith…Jan 14, 2010
  • K063578PROMOS Inclination set, SIZE 24mm, REF 42 184, S&N 75006724, QTY: (1), STERILE R, Smith…Jan 14, 2010
  • K063578PROMOS Inclination set, SIZE 22mm, REF 42 182, S&N 75006723, QTY: (1), STERILE R, Smith…Jan 14, 2010
  • K063578PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith…Jan 14, 2010
  • K022204VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus…Nov 13, 2006
  • K982859UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4…Jul 18, 2006

Other applicant names beginning “Plus”

FDA records each applicant name separately; these may or may not be the same firm.

Plus EV Holdings Dba Intimate Rose 3Plus EV Holdings, Inc. D/B/A Intimate Rose 1