510(k) Report

510(k) · Cleared

Cleared

Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System

K021549510(k) TraditionalCleared Aug 1, 200280-day reviewClass II21 CFR 888.3400

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

Std Mfg., Inc. · KXA Prosthesis, Hip, Femoral, Resurfacing

Cleared on Aug 1, 2002 as substantially equivalent to K994153 (Corin USA, 2000) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1998.

Decided
Aug 1, 2002
Review
80 days
Class
Class II
Product code
KXA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K983452 (1998). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK983452 · Nelson Resurfacing Head · Biomet, Inc. · 199819961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K983452 · Nelson Resurfacing Head · Biomet, Inc. · 19980
  1. Root · 1 generation backK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
  2. This deviceK021549 Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemStd Mfg., Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983452Nelson Resurfacing HeadBiomet, Inc.1998—
0 (this device)K021549Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemStd Mfg., Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K021549, 1998–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Top candidate predicates for a new KXA device

  1. #1 K201219 Biocore9 Femoral Head Resurfacing Componentscore 0.7 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (2)

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
*K994153Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis
Summary page 3
…Prosthesis (CAP) Femoral Resurfacing Prosthesis Head Resurfacing System K Number TBD K994 153 Product Code ~ KXA KXA KXA Regulati…
Corin USA2000—
*K983452Nelson Resurfacing Head
Summary page 4
…CAP) Femoral Resurfacing Prosthesis Head Resurfacing System K Number TBD K994153 K983452 Mechanical Fixation screw installed as Prosthetic press fits into Prosthetic press fits onto Fixation c…
Biomet, Inc.1998—

Also cleared against K994153: 3 other devices →

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?

  • None of the 2 ancestors has a recall.
  • 3 other devices also cite its predicate K994153.

How does its category compare?

All KXA devices

KXA Prosthesis, Hip, Femoral, Resurfacing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXA

1in 2021

2007: 22008: 12010: 12021: 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXA

Too few KXA 510(k)s in any year since 2007 to give a median.

Recalls per year · KXA

1in 2012

2007: 22010: 132012: 1
2007high 13 (2010) · low 0 (2008)2026

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

Adverse event reports per year · KXA

14in 2025

2007: 152008: 222009: 112010: 682011: 5932012: 2,0992013: 2,5222014: 2,4312015: 1,6742016: 6212017: 5802018: 4302019: 9712020: 3732021: 172022: 132023: 52024: 22025: 14
2007high 2,522 (2013) · low 2 (2024)2025

MAUDE reports naming product code KXA, 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
20072—215
20081—022
20090—011
20101—1368
20110—0593
20120—12,099
20130—02,522
20140—02,431
20150—01,674
20160—0621
20170—0580
20180—0430
20190—0971
20200—0373
20211—017
20220—013
20230—05
20240—02
20250—014
20260—0—

What is it indicated for?

Relief of pain and disability, and restoration of hip function within patients who

have radiographic evidence of good bone stock in the femoral head and

acetabulum, with the bearing surface and supportive bone structure of the

acetabulum being normal. The device is a single use implant intended to be used

for cemented, hemi-hip, resurfacing applications only.

Indications for use as stated in the FDA summary.

Also cleared against K994153

3 other devices cite the same predicate.

  • K092198Cormet Cementless Resurfacing Femoral HeadCorin USA · 2010
  • K070292Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 20073 recalls
  • K043542Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005

More from Std Mfg., Inc.

6 FDA decisions under this applicant name. See the company

  • K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 20035 recalls
  • K012362Modification to Vascular Closure DeviceStd Mfg., Inc. · 2001
  • K003169Vascular Closure DeviceStd Mfg., Inc. · 2000
  • K000608Suction Vascular Stapler and Implantable Staple SystemStd Mfg., Inc. · 2000
  • K930427STD Irrigation PumpStd Mfg., Inc. · 1993

Recent decisions in KXA

The KXA category page

  • K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLC · 2021
  • K092198Cormet Cementless Resurfacing Femoral HeadCorin USA · 2010
  • K082673Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008
  • K071053Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007
  • K070292Durom Hip Resurfacing System, Femoral ComponentsZimmer GmbH · 20073 recalls

https://510kreport.com/device/K021549 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021549: Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021549

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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