510(k) Report

FDA applicant

Landos, Inc.

Malvern, PA15 decisions1994–19971 recall

FDA records 15 decisions for Landos, Inc. (Malvern, PA) from 1994 to 1997: 15 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and HWC (Screw, Fixation, Bone). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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 Landos, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Landos, Inc. since 2007.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…6decisions
  • HWCScrew, Fixation, Bone5decisions
  • LZNCement Obturator1decision
  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…1decision
  • JDRStaple, Fixation, Bone1decision
  • HTYPin, Fixation, Smooth1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 1 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.

  • K953111CorailLandos, Inc. · 199610cite it
  • K964226Memory Staple (20 Sizes Available)Landos, Inc. · 19977cite it
  • K962236Scarf Thread-Head ScrewLandos, Inc. · 19963cite it
  • K971069Twist-Off (TM) ScrewLandos, Inc. · 19973cite it
  • K971070Scarf Thread-Head (TM) Head ScrewLandos, Inc. · 19973cite it
  • K962233Twist-Off ScrewLandos, Inc. · 19963cite it

What has FDA decided for it lately?

  • K964226Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  • K971069Twist-Off (TM) ScrewLandos, Inc. · 1997
  • K97106834MM Scarf Thread-Head (TM) ScrewLandos, Inc. · 1997
  • K971070Scarf Thread-Head (TM) Head ScrewLandos, Inc. · 1997
  • K961732KARLandos, Inc. · 1997
  • K97084622.2/+4MM CO CR & Zirconia Femoral HeadLandos, Inc. · 1997
  • K953111CorailLandos, Inc. · 1996
  • K962233Twist-Off ScrewLandos, Inc. · 1996

All 15 as Landos, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K943727BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000…Dec 19, 2022Class II