510(k) Report

510(k) · Cleared

Cleared

Unisyn Plus Hip Stem

K120595510(k) TraditionalCleared Oct 12, 2012227-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

Consensus Orthopedics, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Oct 12, 2012 as substantially equivalent to K003649 (Hayes Medical, Inc., 2001) and 1 other predicate after a 227-day review. Its family tree reaches back 6 generations to 1994.

Decided
Oct 12, 2012
Review
227 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K921308 (1994). 21 ancestors in all, the oldest K921274 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2002: 1 other ancestor1994: 3 other ancestors1999: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor1996: 3 other ancestors1995: 4 other ancestorsK921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK022549 · Restoration Modular System · Howmedica Osteonics Corp. · 2002 · recalledK062383 · Unisyn HA Plasma Modular Hip · Hayes Medical, Inc. · 200619901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 3 other ancestors5 generations back: 8 other ancestors K062383 · Unisyn HA Plasma Modular Hip · Hayes Medical, Inc. · 2006K022549 · Restoration Modular System · Howmedica Osteonics Corp. · 2002 · recalledK013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalled−50
  1. Root · 6 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. 5 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  3. 4 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
  4. 3 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. 2 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
  6. 1 generation backK062383 Unisyn HA Plasma Modular HipHayes Medical, Inc. · 2006
  7. This deviceK120595 Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K921308HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc.19941
−5K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
−4K983404Type 3 Femoral ComponentsHowmedica Corp.19981
−3K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
−2K022549Restoration Modular SystemHowmedica Osteonics Corp.20023
−1K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.2006—
0 (this device)K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199430
199540
199630
199710
199910
200010
200110
200210
FIG. 1 — Lineage of K120595, 1994–2012Source: 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 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
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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
*K003649Triton Hip System
Summary page 2
…s claimed: 50kTrd Name 510k odr510(k) Number Trd ae50k odrRelease Date K003649 Triton Hip System Hayes Medical, Inc. 02/23/2001 K062383 UniSyn HA Plasma Modular Hip…
Hayes Medical, Inc.2001—
*K062383Unisyn HA Plasma Modular Hip
Summary page 2
…Trd ae50k odrRelease Date K003649 Triton Hip System Hayes Medical, Inc. 02/23/2001 K062383 UniSyn HA Plasma Modular Hip Hayes Medical, Inc. 12/21/2006 Non-Clinical Performance Data: The J2NISYN…
Hayes Medical, Inc.2006—

Also cleared against K003649: 1 other device →

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?

  • The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
  • 9 of the 21 ancestors have a recall of any class.
  • 1 other device also cites its predicate K003649.

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. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. A. Proximal femnoral fractures. B. Avascular necrosis of the femoral head. C. Non-union of proximal femoral neck fractures. D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions…

Read the full statement (98 words)

Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.

A. Proximal femnoral fractures.

B. Avascular necrosis of the femoral head.

C. Non-union of proximal femoral neck fractures.

D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tunmorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

UNISYNTM assemblies with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYNTh assemblies with plasmalliA or HA coated bodies are intended for uncemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K003649

1 other device cites the same predicate.

  • K062383Unisyn HA Plasma Modular HipHayes Medical, Inc. · 2006

More from Consensus Orthopedics, Inc.

17 FDA decisions under this applicant name. See the company

  • K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  • K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
  • K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
  • K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
  • K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014

Recent decisions in LWJ

The LWJ category page

  • 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
  • K062978U2 Hip Stem, TI Plasma SprayUnited Orthopedic Corp. · 2007

https://510kreport.com/device/K120595 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120595: Unisyn Plus Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120595

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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