510(k) Report

FDA applicant

Encore Medical, L.P. Dba Djo Surgical

Austin, TX1 decision2022–20221 recall

FDA records 1 decision for Encore Medical, L.P. Dba Djo Surgical (Austin, TX) in 2022: 1 510(k) clearance. All are in product code MBH (Prosthesis, Knee, Patello/Femorotibial…). Its devices cite 1 predicate, 0 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 Encore Medical, L.P. Dba Djo Surgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2022high 1 (2023) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Encore Medical, L.P. Dba Djo Surgical by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Encore Medical, L.P. Dba Djo Surgical’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?

  • MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated…1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical · 20221cites it

What has FDA decided for it lately?

  • K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical · 20221 recall

The one decision as Encore Medical, L.P. Dba Djo Surgical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K212941EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF…Feb 28, 2023Class II

Other applicant names beginning “Encore”

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

Encore Orthopedics, Inc. 85Encore Medical L.P. 85Encore Guards 2Encore Products, Inc. 2Encore Medical, L.P Dba Enovis 2Encore, Inc. 1Encore Medical, L.P. (Dba Enovis) 1Encore Technology, Inc. 1