510(k) Report

510(k) · Cleared

Cleared

Conserve Pressfit Femoral Component

K082673510(k) TraditionalCleared Dec 12, 200888-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

Wrightmedicaltechnologyinc · KXA Prosthesis, Hip, Femoral, Resurfacing

Cleared on Dec 12, 2008 as substantially equivalent to K062960 (Wrightmedicaltechnologyinc, 2006) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.

Decided
Dec 12, 2008
Review
88 days
Class
Class II
Product code
KXA
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K983452 (1998). 5 ancestors in all, the oldest K811718 (1981). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1981: 1 other ancestor2018: 1 descendant cleared2024: 1 descendant clearedK983452 · Nelson Resurfacing Head · Biomet, Inc. · 1998×2: 2 generations cleared close together, K021799 (2002), K023188 (2002) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K023188 · Press-Fit Head Resurfacing Device · Biomet Orthopedics, Inc. · 2002K021799 · Cemented Femoral Head Resurfing Device · Biomet Orthopedics, Inc. · 2002K983452 · Nelson Resurfacing Head · Biomet, Inc. · 19980
  1. Root · 3 generations backK983452 Nelson Resurfacing HeadBiomet, Inc. · 1998
  2. 2 generations backK021799 Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc. · 2002
  3. 1 generation backK023188 Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002
  4. This deviceK082673 Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008
  5. Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
  6. Descendant · 2 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all
  • K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
  • K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K983452Nelson Resurfacing HeadBiomet, Inc.1998—
−2K021799Cemented Femoral Head Resurfing DeviceBiomet Orthopedics, Inc.2002—
−1K023188Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc.2002—
0 (this device)K082673Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc2008—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)2018—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202410
FIG. 1 — Lineage of K082673, 1998–2024Source: 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
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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
*K062960Conserve Femoral Resurfacing Component
Summary page 2
…tions for use, design, and material of the CONSERVE® Pressfit Femoral Resurfacing Component are substantially equivalent to the CONSERVE® Cemented Femoral Component (K062960) and the Biomet Pressfit Head Resurfacing Device (K023188). The fundamental scientific technology of the modified device has no…
Wrightmedicaltechnologyinc2006—
*K023188Press-Fit Head Resurfacing Device
Summary page 2
…t Femoral Resurfacing Component are substantially equivalent to the CONSERVE® Cemented Femoral Component (K062960) and the Biomet Pressfit Head Resurfacing Device (K023188). The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety an…
Biomet Orthopedics, Inc.2002—

Also cleared against K062960: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181

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?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K173898 (Microport Orthopedics Inc. (Mpo), 2018) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K062960.

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. 2008, this device’s year, is highlighted.

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?

The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K082673: Conserve Pressfit Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082673

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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