510(k) · Cleared
ClearedPeri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 19, 2005 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 6 other predicates after a 21-day review. Its family tree reaches back 6 generations to 1996. 1 of the 612 devices in its family, counting itself, has a Class I recall. 584 later devices descend from it.
- Decided
- Jul 19, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K962616 (1996). 27 ancestors in all, the oldest K890939 (1989). 584 later devices descend from it, 18 citing it directly. 1 of the 612 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 4 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 3 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 1 generation backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- This deviceK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · cites it directly · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 3 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 4 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
Showing 5 of 584 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 584 · See all- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · cites it directly495descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 3 generations on228descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 3 generations on161descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 4 generations on118descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −5 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −4 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −3 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −1 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| 0 (this device) | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +1 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +3 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +4 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 14 | 0 |
| 2013 | 11 | 0 |
| 2014 | 26 | 0 |
| 2015 | 30 | 0 |
| 2016 | 23 | 0 |
| 2017 | 44 | 0 |
| 2018 | 25 | 0 |
| 2019 | 32 | 0 |
| 2020 | 39 | 0 |
| 2021 | 46 | 1 |
| 2022 | 35 | 0 |
| 2023 | 44 | 0 |
| 2024 | 60 | 0 |
| 2025 | 54 | 0 |
| 2026 | 71 | 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.
1 device in this family has a Class I recall. 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? (7)
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 |
|---|---|---|---|
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…tion: PERI-LOC° Locking Bone Mates and Locking Bone Screws for the Upper Extremity are line additions to the PERI-LOC ° Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone pl… | 2003 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 1…features, overall indications for use, and material composition. • PERI-LOC ° Periarficular Locked Plating System - K033669 * Synthes LCP Proximal Humerus Plates - K041860 * Synthes 3 5mm LCP Distal Humerus System - K033995 * Synthes Small Fragment DCL System - K000684 * Howmedica Osteonics Num… | 2004 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 1…omposition. • PERI-LOC ° Periarficular Locked Plating System - K033669 * Synthes LCP Proximal Humerus Plates - K041860 * Synthes 3 5mm LCP Distal Humerus System - K033995 * Synthes Small Fragment DCL System - K000684 * Howmedica Osteonics Numelock IIPolyaxial Locking System - K041709 * Acumed,… | 2004 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…Plating System - K033669 * Synthes LCP Proximal Humerus Plates - K041860 * Synthes 3 5mm LCP Distal Humerus System - K033995 * Synthes Small Fragment DCL System - K000684 * Howmedica Osteonics Numelock IIPolyaxial Locking System - K041709 * Acumed, Inc. Congruent Bone Plate System - K012655 *… | 2000 |
| * | K041709 | Numelock II SystemSummary page 1…41860 * Synthes 3 5mm LCP Distal Humerus System - K033995 * Synthes Small Fragment DCL System - K000684 * Howmedica Osteonics Numelock IIPolyaxial Locking System - K041709 * Acumed, Inc. Congruent Bone Plate System - K012655 * Hand Innovations, Inc. Distal Volar Radius Anatomical Plate System - K… | 2004 |
| * | K012655 | Congruent Bone Plate SystemSummary page 1…3995 * Synthes Small Fragment DCL System - K000684 * Howmedica Osteonics Numelock IIPolyaxial Locking System - K041709 * Acumed, Inc. Congruent Bone Plate System - K012655 * Hand Innovations, Inc. Distal Volar Radius Anatomical Plate System - K050932… | 2001 |
| * | K050932 | Distal Volar Radius Anatomical Plate SystemSummary page 1…lock IIPolyaxial Locking System - K041709 * Acumed, Inc. Congruent Bone Plate System - K012655 * Hand Innovations, Inc. Distal Volar Radius Anatomical Plate System - K050932 Page 1of 1… | 2005 |
What descends from it? (584)
See all 58418 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071563 | Peri-Loc Periarticular Locked Plating System | 2007 | 495 |
| K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | 2006 | 108 |
| K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | 2008 | 87 |
| K083032 | Peri-Loc Bone Plating and Screw System | 2009 | 77 |
| K083286 | Orthopediatrics Pediloc Locking Plate System | 2009 | 60 |
| K092015 | Peri-Loc Periarticular Locked Plating System | 2009 | 41 |
| K100325 | Peri-Loc Locking Hole Inserts and Cable Accessories | 2010 | 38 |
| K081106 | Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the… | 2008 | 34 |
| K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | 2013 | 33 |
| K060156 | Straight Plate with Angular Stability & Screw System | 2006 | 27 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 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 1.6 years on median.
- 7 of the 27 ancestors have a recall of any class.
- Of its descendants, K071563 (Smith & Nephew, Inc., 2007) has gone furthest, with 495 descendants of its own.
- 27 other devices also cite its predicate K033669.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
Components in the PERI-LOC Periarticular Locked Plating System are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051735
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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