510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Aptus Titanium Osteosynthesis System

K051567510(k) TraditionalCleared Aug 23, 200570-day reviewClass II21 CFR 888.3030Recalls 1

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

Medartis, Inc. · HRS Plate, Fixation, Bone

Cleared on Aug 23, 2005 as substantially equivalent to K961497 (Howmedica, Inc., 1996) and 5 other predicates after a 70-day review. Its family tree reaches back 4 generations to 1996. 157 later devices descend from it. It has been recalled once.

Decided
Aug 23, 2005
Review
70 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
6

Its longest line of descent runs back 4 generations to K962616 (1996). 14 ancestors in all, the oldest K885250 (1989). 157 later devices descend from it, 22 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2000: 2 other ancestors1996: 3 other ancestors2002: 1 other ancestor1998: 1 other ancestor1989: 1 other ancestor2023: 14 descendants cleared2025: 16 descendants cleared2022: 10 descendants cleared2018: 9 descendants cleared2016: 6 descendants cleared2019: 7 descendants cleared2020: 7 descendants cleared2012: 2 descendants cleared2014: 11 descendants cleared2026: 16 descendants cleared2010: 3 descendants cleared2006: 1 descendant cleared2011: 3 descendants cleared2017: 14 descendants cleared2015: 2 descendants cleared2021: 6 descendants cleared2013: 5 descendants cleared2008: 1 descendant cleared2024: 23 descendants cleared2009: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 22 descendants2 generations forward: 46 descendants3 generations forward: 48 descendants4 generations forward: 25 descendants5 generations forward: 11 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 19960+5
  1. Root · 4 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 3 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 2 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 1 generation backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. This deviceK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005
  6. Descendant · cites it directly · 81 of its ownK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
  7. Descendant · cites it directly · 71 of its ownK103332 Aptus Ulna PlatesMedartis AG · 2011
  8. Descendant · 2 generations on · 61 of its ownK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
  9. Descendant · cites it directly · 59 of its ownK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
  10. Descendant · 3 generations on · 58 of its ownK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010

Showing 5 of 157 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 12010: 32011: 32012: 22013: 52014: 112015: 22016: 62017: 142018: 92019: 72020: 72021: 62022: 102023: 142024: 232025: 162026: 16
2006high 23 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 157 · See all
  • K062498Profyle SystemHowmedica Osteonics Corp. · 2006 · cites it directly81descendants
  • K103332Aptus Ulna PlatesMedartis AG · 2011 · cites it directly71descendants
  • K073527Variax Elbow SystemHowmedica Osteonics Corp. · 2008 · 2 generations on61descendants
  • K142906APTUS Wrist 2.5 SystemMedartis AG · 2015 · cites it directly59descendants
  • K101056Variax Elbow SystemHowmedica Osteonics Corp. · 2010 · 3 generations on58descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−3K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−2K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−1K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
0 (this device)K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.2005—
+1K062498Profyle SystemHowmedica Osteonics Corp.20061
+1K103332Aptus Ulna PlatesMedartis AG2011—
+2K073527Variax Elbow SystemHowmedica Osteonics Corp.2008—
+1K142906APTUS Wrist 2.5 SystemMedartis AG2015—
+3K101056Variax Elbow SystemHowmedica Osteonics Corp.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199630
199810
200020
200210
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200910
201030
201130
201220
201350
2014110
201520
201660
2017140
201890
201970
202070
202160
2022100
2023140
2024230
2025160
2026160
FIG. 1 — Lineage of K051567, 1996–2026Source: 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? (6)

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
*K961497Profyle Titanium Hand and Small Fragment System
Summary page 2
…g predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: ProfyleTM Titanium Hand and Small Fragment System (K961497) from Howmedica (Stryker); Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger; and Distal Radius…
Howmedica, Inc.1996—
*K040022Stryker Leibinger Universal Distal Radius System
Summary page 2
…valent to pre-amendment devices: ProfyleTM Titanium Hand and Small Fragment System (K961497) from Howmedica (Stryker); Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger; and Distal Radius Fracture Repair System (K002775, K023007, K030198) and Fragment Plate System (K041081)…
Stryker Leibinger2004—
*K002775Distal Volar Radius Fracture Repair System
Summary page 2
…System (K961497) from Howmedica (Stryker); Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger; and Distal Radius Fracture Repair System (K002775, K023007, K030198) and Fragment Plate System (K041081) from Hand Innovations.…
Hand Innovations, Inc.2000—
*K023007Distal Radius Fracture Repair System
Summary page 2
…K961497) from Howmedica (Stryker); Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger; and Distal Radius Fracture Repair System (K002775, K023007, K030198) and Fragment Plate System (K041081) from Hand Innovations.…
Hand Innovations, Inc.2002—
*K030198Hand Innovations, Inc. Distal Radius Fracture Repair System
Summary page 2
…from Howmedica (Stryker); Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger; and Distal Radius Fracture Repair System (K002775, K023007, K030198) and Fragment Plate System (K041081) from Hand Innovations.…
Hand Innovations, Inc.2003—
*K041081Fragment Plate System, Screws, Pins and K-Wires
Summary page 2
…eibinger Universal Distal Radius System (K040022) from Stryker Leibinger; and Distal Radius Fracture Repair System (K002775, K023007, K030198) and Fragment Plate System (K041081) from Hand Innovations. Page 2 of 2 === Page…
Hand Innovations, Inc.20041

Also cleared against K961497: 8 other devices →

What descends from it? (157)

See all 157

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

NumberDeviceApplicantDecidedDescendants
K062498Profyle SystemHowmedica Osteonics Corp.200681
K103332Aptus Ulna PlatesMedartis AG201171
K142906APTUS Wrist 2.5 SystemMedartis AG201559
K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.201446
K102537Aptus 1.5 TrilockMedartis AG201019
K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615
K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228
K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178
K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128
K132769Acumed Hand Plating SystemAcumed, LLC20147

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 9, 2026Class IIZ-1549-2026Labeling mix-upsMix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • 2 of the 14 ancestors have a recall of any class.
  • Of its descendants, K062498 (Howmedica Osteonics Corp., 2006) has gone furthest, with 81 descendants of its own.
  • 8 other devices also cite its predicate K961497.

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?

The APTUS® Titanium Fixation System is intended for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group: Management of the fractures of the distal, middle and proximal phalanges and metacarpals Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures DIP and PIP arthrodoses…

Read the full statement (130 words)

The APTUS® Titanium Fixation System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS® Hand group:

Management of the fractures of the distal, middle and proximal phalanges and metacarpals

Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures

DIP and PIP arthrodoses

APTUS® Radius 2.5 group:

Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures

Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

Indications for use as stated in the FDA summary.

Also cleared against K961497

8 other devices cite the same predicate.

  • K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 20141 recall
  • K111266Easylock OsteosystemTriMed, Inc. · 2011
  • K071797Mondeal Hand Contour SystemMondeal Medical Systems GmbH · 2007
  • K062498Profyle SystemHowmedica Osteonics Corp. · 20061 recall
  • K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
  • K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004

More from Medartis, Inc.

5 FDA decisions under this applicant name. See the company

  • K232324StealthFix Intraosseous Fixation SystemMedartis, Inc. · 2023
  • K052061Modus Imf Screws 2.0Medartis, Inc. · 2005
  • K051946Modus Modular Distraction Osteogenesis SystemMedartis, Inc. · 2005
  • K050934Modus Titanium Osteosynthesis SystemMedartis, Inc. · 2005

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/K051567 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051567: Aptus Titanium Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051567

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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