510(k) Report

510(k) · Cleared

Cleared

Stryker Leibinger Universal Distal Radius System

K040022510(k) TraditionalCleared Mar 12, 200465-day reviewClass II21 CFR 888.3030

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

Stryker Leibinger · HRS Plate, Fixation, Bone

Cleared on Mar 12, 2004 as substantially equivalent to K981283 (Howmedica, Inc., 1998) and 2 other predicates after a 65-day review. Its family tree reaches back 2 generations to 1989. 202 later devices descend from it.

Decided
Mar 12, 2004
Review
65 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K885250 (1989). 5 ancestors in all. 202 later devices descend from it, 12 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor2005: 1 descendant cleared2022: 14 descendants cleared2004: 1 descendant cleared2013: 11 descendants cleared2008: 1 descendant cleared2011: 4 descendants cleared2006: 1 descendant cleared2015: 6 descendants cleared2012: 3 descendants cleared2014: 14 descendants cleared2010: 5 descendants cleared2023: 16 descendants cleared2025: 19 descendants cleared2018: 11 descendants cleared2016: 8 descendants cleared2019: 8 descendants cleared2020: 9 descendants cleared2026: 22 descendants cleared2017: 15 descendants cleared2021: 7 descendants cleared2009: 1 descendant cleared2024: 25 descendants clearedK885250 · Alta Tibial/Upper Extremity Metaphyseal Plate Sys · Howmedica Corp. · 1989K981283 · Rogachefsky Distal Radius Plates · Howmedica, Inc. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 12 descendants2 generations forward: 51 descendants3 generations forward: 76 descendants4 generations forward: 43 descendants5 generations forward: 12 descendants6 generations forward: 7 descendants7 generations forward: 1 descendant K981283 · Rogachefsky Distal Radius Plates · Howmedica, Inc. · 1998K885250 · Alta Tibial/Upper Extremity Metaphyseal Plate Sys · Howmedica Corp. · 19890+5
  1. Root · 2 generations backK885250 Alta Tibial/Upper Extremity Metaphyseal Plate SysHowmedica Corp. · 1989
  2. 1 generation backK981283 Rogachefsky Distal Radius PlatesHowmedica, Inc. · 1998
  3. This deviceK040022 Stryker Leibinger Universal Distal Radius SystemStryker Leibinger · 2004
  4. Descendant · cites it directly · 157 of its ownK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
  5. Descendant · cites it directly · 81 of its ownK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
  6. Descendant · cites it directly · 80 of its ownK100271 Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010
  7. Descendant · 2 generations on · 71 of its ownK103332 Aptus Ulna PlatesMedartis AG · 2011
  8. Descendant · cites it directly · 61 of its ownK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008

Showing 5 of 202 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12008: 12009: 12010: 52011: 42012: 32013: 112014: 142015: 62016: 82017: 152018: 112019: 82020: 92021: 72022: 142023: 162024: 252025: 192026: 22
2004high 25 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 202 · See all
  • K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · cites it directly157descendants
  • K062498Profyle SystemHowmedica Osteonics Corp. · 2006 · cites it directly81descendants
  • K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010 · cites it directly80descendants
  • K103332Aptus Ulna PlatesMedartis AG · 2011 · 2 generations on71descendants
  • K073527Variax Elbow SystemHowmedica Osteonics Corp. · 2008 · cites it directly61descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K885250Alta Tibial/Upper Extremity Metaphyseal Plate SysHowmedica Corp.1989—
−1K981283Rogachefsky Distal Radius PlatesHowmedica, Inc.1998—
0 (this device)K040022Stryker Leibinger Universal Distal Radius SystemStryker Leibinger2004—
+1K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051
+1K062498Profyle SystemHowmedica Osteonics Corp.20061
+1K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.2010—
+2K103332Aptus Ulna PlatesMedartis AG2011—
+1K073527Variax Elbow SystemHowmedica Osteonics Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200810
200910
201050
201140
201230
2013110
2014140
201560
201680
2017150
2018110
201980
202090
202170
2022140
2023160
2024250
2025190
2026220
FIG. 1 — Lineage of K040022, 1989–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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
*K981283Rogachefsky Distal Radius Plates
Summary page 1
…gonal application. SUBSTANTIAL EQUIVALENCY INFORMATION The Stryker®k Leibinger Universal1 Distal Radius System is substantially equivalent to legally marketed K98 1283 Rogachefsky Distal Radius Plates,, K96 1496 Radius Reconstruction Plating System, and KO014263 Universal Mandible System.…
Howmedica, Inc.1998—
*K961496R.R.P.S. Radius Reconstrution Plating System
Summary page 1
…CY INFORMATION The Stryker®k Leibinger Universal1 Distal Radius System is substantially equivalent to legally marketed K98 1283 Rogachefsky Distal Radius Plates,, K96 1496 Radius Reconstruction Plating System, and KO014263 Universal Mandible System. DEPARTMENT OF HEALT1l & HUMAN…
Howmedica, Inc.1996—
*K014263Newgen/Universal Mandibular System
Summary page 1
…Distal Radius System is substantially equivalent to legally marketed K98 1283 Rogachefsky Distal Radius Plates,, K96 1496 Radius Reconstruction Plating System, and KO014263 Universal Mandible System. DEPARTMENT OF HEALT1l & HUMAN SERVICES Pu…
Stryker Instruments20021

What descends from it? (202)

See all 202

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

NumberDeviceApplicantDecidedDescendants
K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.2005157
K062498Profyle SystemHowmedica Osteonics Corp.200681
K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.201080
K073527Variax Elbow SystemHowmedica Osteonics Corp.200861
K142906APTUS Wrist 2.5 SystemMedartis AG201559
K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156
K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420
K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320
K133246Zimmer Distal Radius Plating SystemZimmer, Inc.20132
K120015Osteomed Wrist Plating SystemOsteomed LP20122

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 15 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K051567 (Medartis, Inc., 2005) has gone furthest, with 157 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.

Indications for use as stated in the FDA summary.

More from Stryker Leibinger

12 FDA decisions under this applicant name. See the company

  • K052871Stryker Custom TI ImplantStryker Leibinger · 2005
  • K043250Stryker Patient Specific Polymer ImplantStryker Leibinger · 20054 recalls
  • K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004
  • K022579Stryker Navigation System-Knee ModuleStryker Leibinger · 20037 recalls
  • K023449Non-Invasive Patient Fixation SystemStryker Leibinger · 2003

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K040022 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040022: Stryker Leibinger Universal Distal Radius System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040022

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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