510(k) Report

510(k) · Cleared

Cleared

H.N. Total Hip Prosthesis

K901594510(k) TraditionalCleared Aug 3, 1990120-day reviewClass II21 CFR 888.3360

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

Med-Tek Corp. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Aug 3, 1990 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 3, 1990
Review
120 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1990200020102020
  1. This deviceK901594 H.N. Total Hip ProsthesisMed-Tek Corp. · 1990
  2. Descendant · cites it directly · 0 of its ownK972690 Zirconia Ceramic Femoral HeadZimmer, Inc. · 1997
  3. Descendant · cites it directly · 0 of its ownK971752 Zirconia Ceramic Femoral Head (12/14 Taper)Zimmer, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K972690Zirconia Ceramic Femoral HeadZimmer, Inc. · 1997 · cites it directly0descendants
  • K971752Zirconia Ceramic Femoral Head (12/14 Taper)Zimmer, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901594H.N. Total Hip ProsthesisMed-Tek Corp.1990—
+1K972690Zirconia Ceramic Femoral HeadZimmer, Inc.1997—
+1K971752Zirconia Ceramic Femoral Head (12/14 Taper)Zimmer, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
FIG. 1 — Lineage of K901594, 1990–1997Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LWJ? 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?

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

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972690Zirconia Ceramic Femoral HeadZimmer, Inc.19970
K971752Zirconia Ceramic Femoral Head (12/14 Taper)Zimmer, Inc.19970

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, K972690 (Zimmer, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

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

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—

More from Med-Tek Corp.

16 FDA decisions under this applicant name. See the company

  • K903234F-19 Total Hip ProsthesisMed-Tek Corp. · 1990
  • K901687F-24 Femoral Hip ProsthesisMed-Tek Corp. · 1990
  • K901451F-20 Cemented Metal-Backed Acetabular CupMed-Tek Corp. · 1990
  • K900428Anesthesia Breathing CircuitsMed-Tek Corp. · 1990
  • K901626H.N. Metal Backed Acetabular Cup, NoncementedMed-Tek Corp. · 1990

Recent decisions in LWJ

The LWJ category page

  • K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
  • K103518Trinity Acetabular SystemCorin USA · 2011
  • K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
  • K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007

https://510kreport.com/device/K901594 · printed Nov 6, 2026

Cite this page

510(k) Report. “K901594: H.N. Total Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901594

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026