510(k) Report

510(k) · Cleared

Cleared

RHS

K060438510(k) TraditionalCleared Apr 18, 200656-day reviewClass II21 CFR 888.3160

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

Tornier · JDB Prosthesis, Elbow, Semi-Constrained, Cemented

Cleared on Apr 18, 2006 as substantially equivalent to K994041 (Tornier, Inc., 2000) and 2 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1999. 18 later devices descend from it.

Decided
Apr 18, 2006
Review
56 days
Class
Class II
Product code
JDB
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K984290 (1999). 10 ancestors in all, the oldest K944507 (1995). 18 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor2010: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2018: 1 descendant cleared2023: 2 descendants cleared2024: 4 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared2022: 1 descendant clearedK984290 · Implex Radial Head Replacement System · Implex Corp. · 1999K012551 · Liverpool Radial Head Replacement Device · Biomet, Inc. · 2002K040611 · Modular Radial Head Replacement Device · Biomet, Inc. · 2004 · recalledK051385 · Explor Modular Radial Head Replacement Device · Biomet, Inc. · 2005 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K051385 · Explor Modular Radial Head Replacement Device · Biomet, Inc. · 2005 · recalledK040611 · Modular Radial Head Replacement Device · Biomet, Inc. · 2004 · recalledK012551 · Liverpool Radial Head Replacement Device · Biomet, Inc. · 2002K984290 · Implex Radial Head Replacement System · Implex Corp. · 19990+5
  1. Root · 4 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
  2. 3 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
  3. 2 generations backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
  4. 1 generation backK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
  5. This deviceK060438 RHSTornier · 2006
  6. Descendant · cites it directly · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
  7. Descendant · 2 generations on · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
  8. Descendant · 3 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
  9. Descendant · 4 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021
  10. Descendant · 2 generations on · 2 of its ownK171004 Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12016: 12017: 12018: 12020: 32021: 22022: 12023: 22024: 42025: 1
2010high 4 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 18 · See all
  • K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · cites it directly16descendants
  • K153452Salto XT, Salto TalarisTornier S.A.S. · 2016 · 2 generations on15descendants
  • K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · 3 generations on8descendants
  • K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 4 generations on2descendants
  • K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K984290Implex Radial Head Replacement SystemImplex Corp.1999—
−3K012551Liverpool Radial Head Replacement DeviceBiomet, Inc.2002—
−2K040611Modular Radial Head Replacement DeviceBiomet, Inc.20041
−1K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc.20052
0 (this device)K060438RHSTornier2006—
+1K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.201319
+2K153452Salto XT, Salto TalarisTornier S.A.S.20168
+3K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2020—
+4K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.2021—
+2K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
199910
200020
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201610
201710
201810
202030
202120
202210
202320
202440
202510
FIG. 1 — Lineage of K060438, 1999–2025Source: 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 JDB? 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 JDB device

  1. #1 K222807 TEMA Elbow system - Line extensionscore 4.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K994041Tornier Bipolar Radial Head Prosthesis
Summary page 1
…ice class: Class 11 Classification panel: Orthopedic Product code: JDB &KWI 5) Equivalent I Predicate device Radial Head Prosthesis, Tomier, K99404 1 Radial Head, Avanta, K023604 Explor, Biomet, K051385…
Tornier, Inc.2000—
*K023604Modification to Radial Head Implant
Summary page 1
…1 Classification panel: Orthopedic Product code: JDB &KWI 5) Equivalent I Predicate device Radial Head Prosthesis, Tomier, K99404 1 Radial Head, Avanta, K023604 Explor, Biomet, K051385 Page 1/…
Avanta Orthopaedics, Inc.200218
*K051385Explor Modular Radial Head Replacement Device
Summary page 1
…Orthopedic Product code: JDB &KWI 5) Equivalent I Predicate device Radial Head Prosthesis, Tomier, K99404 1 Radial Head, Avanta, K023604 Explor, Biomet, K051385 Page 1/ page 2 TORNIER…
Biomet, Inc.20052

Also cleared against K994041: 1 other device →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.201316
K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc.20100

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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • 6 of the 10 ancestors have a recall of any class.
  • Of its descendants, K130533 (Tornier S.A.S., 2013) has gone furthest, with 16 descendants of its own.
  • 1 other device also cites its predicate K994041.

How does its category compare?

All JDB devices

JDB Prosthesis, Elbow, Semi-Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDB

1in 2022

2007: 22010: 22017: 12018: 12020: 12022: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDB

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

Recalls per year · JDB

1in 2024

2011: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JDB

38in 2025

2007: 32008: 132009: 102010: 72011: 62012: 62013: 22014: 52015: 442016: 112017: 262018: 392019: 312020: 322021: 232022: 582023: 292024: 1632025: 38
2007high 163 (2024) · low 2 (2013)2025

MAUDE reports naming product code JDB, 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—03
20080—013
20090—010
20102—07
20110—16
20120—06
20130—02
20140—05
20150—044
20160—011
20171—026
20181—039
20190—031
20201—032
20210—023
20221—058
20230—029
20240—1163
20250—038
20260—0—

What is it indicated for?

The RHS is intended for:

1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

a. Joint destruction and/or subluxation visible on x-ray

b. Resistance to conservative treatment

2) Primary replacement after fracture of the radial head

3) Symptomatic sequelae after radial head resection

4) Revision following failed radial head arthroplasty

The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Indications for use as stated in the FDA summary.

Also cleared against K994041

1 other device cites the same predicate.

  • K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 201319 recalls

More from Tornier

44 FDA decisions under this applicant name. See the company

  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K094013HLS Kneetec SystemTornier · 2011
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010

Recent decisions in JDB

The JDB category page

  • K222807TEMA Elbow system - Line extensionLima Corporate S.P.A. · 20221 recall
  • K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. · 2020
  • K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018
  • K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
  • K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 20109 recalls

https://510kreport.com/device/K060438 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060438: RHS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060438

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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