510(k) · Cleared
ClearedUniversal Distal Radius 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 Jun 19, 2013 as substantially equivalent to K061917 (Newclip Technics, 2006) and 4 other predicates after a 91-day review. Its family tree reaches back 9 generations to 1996. 5 later devices descend from it.
- Decided
- Jun 19, 2013
- Review
- 91 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K962616 (1996). 40 ancestors in all, the oldest K890939 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK100944 Clavicle Locking Plate SystemNewclip Technics · 2010
- This deviceK130774 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 · cites it directly · 1 of its ownK170843 Alians Fragment SpecificNewclip Technics · 2017
- Descendant · 3 generations on · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK213214 Xpert WristNewclip Technics · 2021
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK100944 Clavicle Locking Plate SystemNewclip Technics · 2010
- This deviceK130774 Universal Distal Radius SystemNewclip Technics · 2013
Most influential descendants
Showing 5 of 5 · See all- 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 · cites it directly1descendant
- K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026 · 3 generations on0descendants
- K213214Xpert WristNewclip Technics · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −1 | K100944 | Clavicle Locking Plate System | Newclip Technics | 2010 | — |
| 0 (this device) | 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 | — |
| +1 | K170843 | Alians Fragment Specific | Newclip Technics | 2017 | — |
| +3 | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026 | — |
| +2 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K061917 | Distal Radius Locking Plating SystemSummary page 1…ne (21 CFR part. 888.3040) 3. Predicate or legally marketed devices which are substantially equivalent: » The Distal Radius Locking Plating System of Newclip Technics (K061917). . The Clavicle Locking Plating System of Newclip Technics (K100944). » Synthes Locking Distal Radius Plating System (K102694)… | 2006 |
| * | K100944 | Clavicle Locking Plate SystemSummary page 1…hich are substantially equivalent: » The Distal Radius Locking Plating System of Newclip Technics (K061917). . The Clavicle Locking Plating System of Newclip Technics (K100944). » Synthes Locking Distal Radius Plating System (K102694). « Acumed Congruent Bone Plate System (K102998). ' y « Medartis AGAP… | 2010 |
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 1…king Plating System of Newclip Technics (K061917). . The Clavicle Locking Plating System of Newclip Technics (K100944). » Synthes Locking Distal Radius Plating System (K102694). « Acumed Congruent Bone Plate System (K102998). ' y « Medartis AGAPTUS® 2.0 Radial Head System (K090053). Section 4 ‘ \ Page… | 2010 |
| * | K102998 | Congruent Bone Plate SystemSummary page 1…. . The Clavicle Locking Plating System of Newclip Technics (K100944). » Synthes Locking Distal Radius Plating System (K102694). « Acumed Congruent Bone Plate System (K102998). ' y « Medartis AGAPTUS® 2.0 Radial Head System (K090053). Section 4 ‘ \ Page 1 of 3 K130774 NEWCLIP-"{ »I3ad… | 2011 |
| * | K090053 | Aptus 2.0 Radial Head SystemSummary page 1…cs (K100944). » Synthes Locking Distal Radius Plating System (K102694). « Acumed Congruent Bone Plate System (K102998). ' y « Medartis AGAPTUS® 2.0 Radial Head System (K090053). Section 4 ‘ \ Page 1 of 3 K130774 NEWCLIP-"{ »I3ad 4. Description of the device: Materials: Function: Cha… | 2009 |
What descends from it? (5)
2 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 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 40 ancestors have a recall of any class.
- Of its descendants, K142502 (Newclip Technics, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K061917.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Universal Distal Radius System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130774: Universal Distal Radius System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130774
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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