510(k) Report

510(k) · Cleared

Cleared

Bipolar Hip System

K892398510(k) TraditionalCleared May 23, 198946-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

Orthomet, Inc. · KXA Prosthesis, Hip, Femoral, Resurfacing

Cleared on May 23, 1989 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 23, 1989
Review
46 days
Class
Class II
Product code
KXA
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared1990200020102020
  1. This deviceK892398 Bipolar Hip SystemOrthomet, Inc. · 1989
  2. Descendant · cites it directly · 0 of its ownK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K892398Bipolar Hip SystemOrthomet, Inc.1989—
+1K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K892398, 1989–2024Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240

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?

  • Of its descendants, K240046 (Microport Orthopedics, 2024) has gone furthest, with 0 descendants of its own.

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—

More from Orthomet, Inc.

60 FDA decisions under this applicant name. See the company

  • K936310Orthomet HMC Femoral Stem ComponentOrthomet, Inc. · 1995
  • K945783Orthomet Titanium Hybrid Femoral StemOrthomet, Inc. · 1995
  • K943873Orthomet Anatomically Guided Carpal Tunnel Release SYOrthomet, Inc. · 1995
  • K944752Orthomet Resurfacing Femoral ComponentOrthomet, Inc. · 1994
  • K930771Perfecta Total Hip System Coated Cocr Femoral StemOrthomet, Inc. · 1994

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/K892398 · printed Nov 4, 2026

Cite this page

510(k) Report. “K892398: Bipolar Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K892398

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026