510(k) · Cleared
ClearedPeri-Loc Periarticular Locked Plating System
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 Aug 8, 2007 as substantially equivalent to K062216 (Smith & Nephew, Inc., 2006) and 4 other predicates after a 62-day review. Its family tree reaches back 7 generations to 1996. 1 of the 525 devices in its family, counting itself, has a Class I recall. 495 later devices descend from it.
- Decided
- Aug 8, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K962616 (1996). 29 ancestors in all, the oldest K890939 (1989). 495 later devices descend from it, 10 citing it directly. 1 of the 525 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 1 generation backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- This deviceK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 2 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
Showing 5 of 495 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 495 · See all- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · cites it directly487descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 2 generations on228descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 2 generations on161descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 3 generations on118descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +1 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +2 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +3 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 20 | 0 |
| 2015 | 24 | 0 |
| 2016 | 12 | 0 |
| 2017 | 36 | 0 |
| 2018 | 21 | 0 |
| 2019 | 28 | 0 |
| 2020 | 35 | 0 |
| 2021 | 43 | 1 |
| 2022 | 33 | 0 |
| 2023 | 42 | 0 |
| 2024 | 58 | 0 |
| 2025 | 51 | 0 |
| 2026 | 67 | 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? (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 |
|---|---|---|---|
| * | K062216 | Peri-Loc Periarticular Locked Plating SystemSummary page 1…cription: PERI-LOC TM Periarticular Locked Plating System - VLP Plates and Screws are line additions to the PERi- LOCTM Periarticular Locked Plating System cleared under K062216. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone pl… | 2006 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…overall indications for use, and material composition. * PERI-LOCTM Periarticular Locked Plating System - K062216 * PERI-LOCTM Periarticular Locked Plating System - K033669 * PERI-LOCTM Periarticular Locked Plating System - K051735 * Smith & Nephew Bone Plate System (TC-100 Plating and Screw Syste… | 2003 |
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary page 1…ERI-LOCTM Periarticular Locked Plating System - K062216 * PERI-LOCTM Periarticular Locked Plating System - K033669 * PERI-LOCTM Periarticular Locked Plating System - K051735 * Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) - K993106 * Synthes One-Third Tubular DCL Plate - KO1 13… | 2005 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 1…lar Locked Plating System - K033669 * PERI-LOCTM Periarticular Locked Plating System - K051735 * Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) - K993106 * Synthes One-Third Tubular DCL Plate - KO1 1335… | 1999 |
| * | K011335 | Synths One-Third Tubular DCL Plate | 2001 |
What descends from it? (495)
See all 49510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | 2009 | 487 |
| 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 |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | 2015 | 15 |
| K170457 | EVOS Small Fragment Lower Extremity Plates | 2017 | 13 |
| K173293 | EVOS Small Fragment Upper Extremity Plates | 2018 | 12 |
| K173166 | ANTHEM Fracture System | 2017 | 11 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP… | 2022 | 2 |
| K140357 | Oic Variable Angle Small Fragment Locking Plate System | 2014 | 2 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 29 ancestors have a recall of any class.
- Of its descendants, K090675 (Smith & Nephew, Inc., 2009) has gone furthest, with 487 descendants of its own.
- 5 other devices also cite its predicate K062216.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.
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/K071563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071563: Peri-Loc Periarticular Locked 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/K071563
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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