510(k) · Cleared
ClearedClavicle Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newclip Technics · HRS Plate, Fixation, Bone
Cleared on Oct 22, 2010 as substantially equivalent to K012655 (Acu Med, Inc., 2001) and 3 other predicates after a 199-day review. Its family tree reaches back 8 generations to 1996. 9 later devices descend from it.
- Decided
- Oct 22, 2010
- Review
- 199 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962616 (1996). 31 ancestors in all, the oldest K890939 (1989). 9 later devices descend from it, 4 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 backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- This deviceK100944 Clavicle Locking Plate SystemNewclip Technics · 2010
- Descendant · cites it directly · 5 of its ownK130774 Universal Distal Radius SystemNewclip Technics · 2013
- Descendant · cites it directly · 2 of its ownK142502 Alians Ulna Locking Plating SystemNewclip Technics · 2014
- Descendant · 2 generations on · 1 of its ownK211592 Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK170843 Alians Fragment SpecificNewclip Technics · 2017
- Descendant · cites it directly · 1 of its ownK112509 Trimed Clavicle Fixation SystemTriMed, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130774Universal Distal Radius SystemNewclip Technics · 2013 · cites it directly5descendants
- K142502Alians Ulna Locking Plating SystemNewclip Technics · 2014 · cites it directly2descendants
- K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021 · 2 generations on1descendant
- K170843Alians Fragment SpecificNewclip Technics · 2017 · 2 generations on1descendant
- K112509Trimed Clavicle Fixation SystemTriMed, Inc. · 2011 · cites it directly1descendant
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 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| 0 (this device) | K100944 | Clavicle Locking Plate System | Newclip Technics | 2010 | — |
| +1 | K130774 | Universal Distal Radius System | Newclip Technics | 2013 | — |
| +1 | K142502 | Alians Ulna Locking Plating System | Newclip Technics | 2014 | — |
| +2 | K211592 | Avanti Orthopaedics Ulnar Shortening System | Avanti Orthopaedics, Inc. | 2021 | — |
| +2 | K170843 | Alians Fragment Specific | Newclip Technics | 2017 | — |
| +1 | K112509 | Trimed Clavicle Fixation System | TriMed, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K012655 | Congruent Bone Plate SystemSummary page 3…~~~~~~Plates 510(K) Number K(100994 K050852 K(012655 K(073186… | 2001 |
| * | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySummary page 1…Inc. (KO 12655), *The Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating System for the Upper Extremity of Smith & Nephew; Inc. (K06 1352), *The 3.5mm LCP Clavicle Plate System of Synthes (K073 186), *The Claviculaplate with Angular Stability Syst… | 2006 |
| * | K073186 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 1…oc Periarticular Locked Plating System for the Upper Extremity of Smith & Nephew; Inc. (K06 1352), *The 3.5mm LCP Clavicle Plate System of Synthes (K073 186), *The Claviculaplate with Angular Stability System of L.T.S. Implantat- Technologie-Systeme GmbH (K050852)… | 2007 |
| * | K050852 | Claviculaplate with Angular Stablity Bone Plate SystemSummary page 1…m LCP Clavicle Plate System of Synthes (K073 186), *The Claviculaplate with Angular Stability System of L.T.S. Implantat- Technologie-Systeme GmbH (K050852). Page 1 of 4 pages NEWCLIuP… | 2005 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 31 ancestors have a recall of any class.
- Of its descendants, K130774 (Newclip Technics, 2013) has gone furthest, with 5 descendants of its own.
- 27 other devices also cite its predicate K012655.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100944: Clavicle Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100944
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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