510(k) Report

510(k) · Cleared

Cleared

Metal Transcend Articulation System

K004043510(k) AbbreviatedCleared Jul 13, 2001196-day reviewClass III21 CFR 888.3320

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

Wrightmedicaltechnologyinc · JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Cleared on Jul 13, 2001 after a 196-day review. The FDA summary names no predicate by number. 131 later devices descend from it.

Decided
Jul 13, 2001
Review
196 days
Class
Class III
Product code
JDL
Recalls
None
Predicates
0

131 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 6 descendants cleared2002: 1 descendant cleared2008: 4 descendants cleared2004: 1 descendant cleared2006: 5 descendants cleared2012: 5 descendants cleared2005: 1 descendant cleared2018: 9 descendants cleared2013: 6 descendants cleared2007: 1 descendant cleared2024: 8 descendants cleared2009: 2 descendants cleared2019: 14 descendants cleared2020: 12 descendants cleared2015: 6 descendants cleared2017: 6 descendants cleared2016: 7 descendants cleared2021: 8 descendants cleared2014: 5 descendants cleared2026: 9 descendants cleared2025: 7 descendants cleared2023: 5 descendants cleared2022: 3 descendants cleared200020052010201520202025
  1. This deviceK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
  2. Descendant · cites it directly · 125 of its ownK021349 Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc · 2002
  3. Descendant · 2 generations on · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
  4. Descendant · 2 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  5. Descendant · 3 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  6. Descendant · 4 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled

Showing 5 of 131 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 12006: 52007: 12008: 42009: 22011: 62012: 52013: 62014: 52015: 62016: 72017: 62018: 92019: 142020: 122021: 82022: 32023: 52024: 82025: 72026: 9
2002high 14 (2019) · low 0 (2003)2026

Most influential descendants

Showing 5 of 131 · See all
  • K021349Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc · 2002 · cites it directly125descendants
  • K042037M2A Magnum SystemBiomet, Inc. · 2004 · 2 generations on116descendants
  • K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 2 generations on74descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 3 generations on73descendants
  • K123392Avenir Muller StemZimmer GmbH · 2013 · 4 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K004043Metal Transcend Articulation SystemWrightmedicaltechnologyinc2001—
+1K021349Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc2002—
+2K042037M2A Magnum SystemBiomet, Inc.2004—
+2K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200613
+3K071723Zimmer Porolock Mis StemZimmer GmbH20082
+4K123392Avenir Muller StemZimmer GmbH20134

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200510
200650
200710
200840
200920
201160
201250
201360
201450
201560
201670
201760
201890
2019140
2020120
202180
202230
202350
202480
202570
202690
FIG. 1 — Lineage of K004043, 2001–2026Source: 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 JDL? 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?

The FDA summary names no predicate by number.

What descends from it? (131)

See all 131

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

NumberDeviceApplicantDecidedDescendants
K021349Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc2002125
K111699Profemur (R) Z Titanium Plasma Sprayed Hip StemWrightmedicaltechnologyinc20113
K111698Profemur (R) E Cementless Hip StemWrightmedicaltechnologyinc20112
K110399Gladiator Plasma Classic Hip StemWrightmedicaltechnologyinc20112

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, K021349 (Wrightmedicaltechnologyinc, 2002) has gone furthest, with 125 descendants of its own.

How does its category compare?

All JDL devices

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

FDA decisions per year · JDL

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDL

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

Recalls per year · JDL

1in 2010

2009: 22010: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JDL

16in 2025

2007: 792008: 672009: 1042010: 1982011: 2712012: 3382013: 4962014: 5192015: 4662016: 2992017: 3362018: 2052019: 1402020: 942021: 682022: 492023: 322024: 272025: 16
2007high 519 (2014) · low 16 (2025)2025

MAUDE reports naming product code JDL, 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
20071—079
20081—067
20090—2104
20100—1198
20110—0271
20120—0338
20130—0496
20140—0519
20150—0466
20160—0299
20170—0336
20180—0205
20190—0140
20200—094
20210—068
20220—049
20230—032
20240—027
20250—016
20260—1—

What is it indicated for?

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2) inflammatory degenerative joint disease such as rheumatoid arthritis;

3) correction of functional deformity; and,

4) revision procedures where other treatments or devices have failed.

Indications for use as stated in the FDA summary.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in JDL

The JDL category page

  • K073499Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008
  • K070785Dynasty Acetabular SystemWrightmedicaltechnologyinc · 2007
  • K061844Dynasty Acetabular Shell and Cocr Acetabular LinerWrightmedicaltechnologyinc · 2006
  • K051995Profemur Renaissance Hip StemWrightmedicaltechnologyinc · 2005
  • K051348Conserve Total Femoral HeadWrightmedicaltechnologyinc · 20052 recalls

https://510kreport.com/device/K004043 · printed Nov 5, 2026

Cite this page

510(k) Report. “K004043: Metal Transcend Articulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K004043

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 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026