510(k) Report

510(k) · Cleared

Cleared

Metal/Metal Hip System

K040354510(k) SpecialCleared Nov 4, 2004266-day reviewClass III21 CFR 888.3330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Encore Medical L.P. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Nov 4, 2004 as substantially equivalent to K003250 (Encore Orthopedics, Inc., 2001) after a 266-day review. Its family tree reaches back 1 generation to 2001.

Decided
Nov 4, 2004
Review
266 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003250 (2001). No later device cites it as a predicate yet.

K003250 · FMP Metal/Metal Acetabular Insert · Encore Orthopedics, Inc. · 20012000200220042006
K003250 · FMP Metal/Metal Acetabular Insert · Encore Orthopedics, Inc. · 20010
  1. Root · 1 generation backK003250 FMP Metal/Metal Acetabular InsertEncore Orthopedics, Inc. · 2001
  2. This deviceK040354 Metal/Metal Hip SystemEncore Medical L.P. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003250FMP Metal/Metal Acetabular InsertEncore Orthopedics, Inc.2001—
0 (this device)K040354Metal/Metal Hip SystemEncore Medical L.P.2004—
FIG. 1 — Lineage of K040354, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003250FMP Metal/Metal Acetabular Insert
Summary page 1
…34-2 and the metal components are manufactured from materials conforming to ASTM F799. The design features of these parts are identical to those previously cleared under K003250.The metal shells are available with outside diameters of 48mm to 66mm (in 2mm increments). The shells accept a polyethylene liner…
Encore Orthopedics, Inc.2001—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
2007high 84 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWA

1,216in 2025

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

What is it indicated for?

Indications for use in total hip replacement include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

Indications for use as stated in the FDA summary.

More from Encore Medical L.P.

82 FDA decisions under this applicant name. See the company

  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P. · 2026
  • K252974EMPOWR KneeEncore Medical L.P. · 2025
  • K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
  • K252141AltiVate Reverse® GlenoidEncore Medical L.P. · 2025

Recent decisions in KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K040354 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040354: Metal/Metal Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040354

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026