510(k) Report

510(k) · Cleared

Cleared

Osteomed Wrist Plating System

K120015510(k) TraditionalCleared Apr 24, 2012112-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

Osteomed LP · HRS Plate, Fixation, Bone

Cleared on Apr 24, 2012 as substantially equivalent to K090522 (Osteomed LP, 2009) and 9 other predicates after a 112-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.

Decided
Apr 24, 2012
Review
112 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
10

Its longest line of descent runs back 7 generations to K962616 (1996). 57 ancestors in all, the oldest K885250 (1989). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 4 other ancestors2006: 1 other ancestor2005: 2 other ancestors2004: 5 other ancestors1993: 2 other ancestors2003: 4 other ancestors2002: 2 other ancestors2001: 5 other ancestors2000: 7 other ancestors1998: 4 other ancestors1996: 5 other ancestors1995: 2 other ancestors1991: 2 other ancestors1999: 2 other ancestors1989: 2 other ancestors1997: 1 other ancestor2015: 1 descendant cleared2016: 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) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 18 other ancestors3 generations back: 16 other ancestors4 generations back: 7 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · 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) · 1996−50
  1. Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 1 generation backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. This deviceK120015 Osteomed Wrist Plating SystemOsteomed LP · 2012
  9. Descendant · cites it directly · 1 of its ownK152145 OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2015
  10. Descendant · 2 generations on · 0 of its ownK161041 OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2015 · cites it directly1descendant
  • K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−6K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−5K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−4K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−3K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−2K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
0 (this device)K120015Osteomed Wrist Plating SystemOsteomed LP2012—
+1K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed2015—
+2K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199120
199320
199520
199650
199710
199840
199920
200070
200150
200220
200340
200450
200520
200610
200940

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
FIG. 1 — Lineage of K120015, 1996–2016Source: 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? (10)

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
*K090522Osteomed Hand Plate and Screw Fixation System
Summary page 1
…in trauma, general surgery and reconstructive procedures. OsteoMed Wrist Plating System implants are intended for single use only. Substantial Equivalence: K090522: OsteoMed Hand Plating System K091614: OsteoMed Foot Plating System K924018: M3 Lag Screw Fixation System === Page 2…
Osteomed LP2009—
*K091614Osteomed Foot Plating System
Summary page 1
…ve procedures. OsteoMed Wrist Plating System implants are intended for single use only. Substantial Equivalence: K090522: OsteoMed Hand Plating System K091614: OsteoMed Foot Plating System K924018: M3 Lag Screw Fixation System…
Osteomed LP2009—
*K924018M3 Lag Screw Fixation System
Summary page 1
…System implants are intended for single use only. Substantial Equivalence: K090522: OsteoMed Hand Plating System K091614: OsteoMed Foot Plating System K924018: M3 Lag Screw Fixation System 0) K040022: Stryker Leibinger Un…
Osteomed Corp.1993—
*K040022Stryker Leibinger Universal Distal Radius System
Summary page 2
…ting System K091614: OsteoMed Foot Plating System K924018: M3 Lag Screw Fixation System 0) K040022: Stryker Leibinger Universal Distal Radius System K051735: PERI-LOC Periarticular Locked Plating System K(083694: Synthes 2.4mm V…
Stryker Leibinger2004—
*K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Summary page 2
…K924018: M3 Lag Screw Fixation System 0) K040022: Stryker Leibinger Universal Distal Radius System K051735: PERI-LOC Periarticular Locked Plating System K(083694: Synthes 2.4mm VA-LOP Two Column Volar Distal Radius Plate K091644: Synthe…
Smith & Nephew, Inc.2005—
*K083694Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates
Summary page 2
…= 0) K040022: Stryker Leibinger Universal Distal Radius System K051735: PERI-LOC Periarticular Locked Plating System K(083694: Synthes 2.4mm VA-LOP Two Column Volar Distal Radius Plate K091644: Synthes (USA) 2.4mm LOP Volar Column Distal Radius Plates K04…
Synthes (Usa)20092
*K091644Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates
Summary page 2
…tryker Leibinger Universal Distal Radius System K051735: PERI-LOC Periarticular Locked Plating System K(083694: Synthes 2.4mm VA-LOP Two Column Volar Distal Radius Plate K091644: Synthes (USA) 2.4mm LOP Volar Column Distal Radius Plates K042355: Synthes (USA) LOP Wrist Fusion Plates K052248: Dorsal Nail Pl…
Synthes (Usa)2009—
*K042355Synthes (Usa) LCP Wrist Fusion Plates
Summary page 2
…eriarticular Locked Plating System K(083694: Synthes 2.4mm VA-LOP Two Column Volar Distal Radius Plate K091644: Synthes (USA) 2.4mm LOP Volar Column Distal Radius Plates K042355: Synthes (USA) LOP Wrist Fusion Plates K052248: Dorsal Nail Plate, Anatomical K062863: OsteoMed Extended 2.0/2.4 Cannulated Screw…
Synthes (Usa)2004—
*K052248Dorsal Nail Plate, Anatomical
Summary page 2
…nthes 2.4mm VA-LOP Two Column Volar Distal Radius Plate K091644: Synthes (USA) 2.4mm LOP Volar Column Distal Radius Plates K042355: Synthes (USA) LOP Wrist Fusion Plates K052248: Dorsal Nail Plate, Anatomical K062863: OsteoMed Extended 2.0/2.4 Cannulated Screw System Plates and screws are supplied in a var…
Hand Innovations, LLC20055
*K062863Osteomed Extended 2.0/2.4CANNULATED Screw System
Summary page 2
…tal Radius Plate K091644: Synthes (USA) 2.4mm LOP Volar Column Distal Radius Plates K042355: Synthes (USA) LOP Wrist Fusion Plates K052248: Dorsal Nail Plate, Anatomical K062863: OsteoMed Extended 2.0/2.4 Cannulated Screw System Plates and screws are supplied in a variety of configurations. The plates and…
Osteomed LP2006—

Also cleared against K090522: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151

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 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 10 of the 57 ancestors have a recall of any class.
  • Of its descendants, K152145 (Osteomed, 2015) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K090522.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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?

OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed Wrist Plating System implants are intended for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K090522

3 other devices cite the same predicate.

  • K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony…Field Orthopaedics Pty, Ltd. · 2020
  • K132769Acumed Hand Plating SystemAcumed, LLC · 2014
  • K111419Osteomed Hand Fusion SystemOsteomed LP · 2011

More from Osteomed LP

29 FDA decisions under this applicant name. See the company

  • K143338Argulated Locking PlatesOsteomed LP · 2015
  • K133691Extrimilock Ankle Plating SystemOsteomed LP · 2014
  • K131445Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013
  • K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
  • K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP · 2012

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/K120015 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120015: Osteomed Wrist Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120015

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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