510(k) · Cleared
ClearedOsteoMed ExtremiLOCK Wrist Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · HRS Plate, Fixation, Bone
Cleared on Dec 21, 2015 as substantially equivalent to K120015 (Osteomed LP, 2012) and 1 other predicate after a 140-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Dec 21, 2015
- Review
- 140 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K962616 (1996). 58 ancestors in all, the oldest K885250 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK120015 Osteomed Wrist Plating SystemOsteomed LP · 2012
- This deviceK152145 OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2015
- Descendant · cites it directly · 0 of its ownK161041 OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2016
Most influential descendants
Showing 1 of 1 · See all- K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K120015 | Osteomed Wrist Plating System | Osteomed LP | 2012 | — |
| 0 (this device) | K152145 | OsteoMed ExtremiLOCK Wrist Plating System | Osteomed | 2015 | — |
| +1 | K161041 | OsteoMed ExtremiLOCK Wrist Plating System | Osteomed | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120015 | Osteomed Wrist Plating SystemSummary page 4…ponent metallic bone fixation appliances and accessories Product Code: HRS, HWC PrimaryPredicate: OsteoMed Wrist Plating System, K120015 Classification Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories; Product Code:… | 2012 |
| * | K083694 | Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius PlatesSummary page 4…nt metallic bone fixation appliances and accessories; Product Code: HRS, HWC; Class: II SecondaryPredicate: Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate, K083694 Classification Name: 21CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories; Product Code: Pr… | 2009 |
| † | K090522 | Osteomed Hand Plate and Screw Fixation System | 2009 |
| † | K091614 | Osteomed Foot Plating System | 2009 |
| † | K063298 | Osteomed Headless Cannulated Screw System | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161041 | OsteoMed ExtremiLOCK Wrist Plating System | 2016 | 0 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 58 ancestors have a recall of any class.
- Of its descendants, K161041 (Osteomed, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
OsteoMed ExtremiLOCK Wrist Plating System is indicated 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 ExtremiLOCK Wrist Plating System implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152145: OsteoMed ExtremiLOCK Wrist Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152145
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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