510(k) · Cleared
Recalled · Class II · 2017Peri-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 Sep 15, 2006 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 1 other predicate after a 45-day review. Its family tree reaches back 3 generations to 1998. 1 of the 511 devices in its family, counting itself, has a Class I recall. 501 later devices descend from it. It has been recalled once.
- Decided
- Sep 15, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981372 (1998). 9 ancestors in all. 501 later devices descend from it, 6 citing it directly. 1 of the 511 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 2 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 1 generation backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- This deviceK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006
- 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 501 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 501 · 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 |
|---|---|---|---|---|---|
| −3 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −2 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| 0 (this device) | K062216 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2006 | — |
| +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 |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 | 13 | 0 |
| 2017 | 38 | 0 |
| 2018 | 21 | 0 |
| 2019 | 28 | 0 |
| 2020 | 36 | 0 |
| 2021 | 44 | 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? (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 |
|---|---|---|---|
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…/ 87 Device Description: PERI-LOC ° Periarticular Locked Plating System - B-Plates 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 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 1…ions for use, and material composition. a PERI-LOC0 Periarticular Locked Plating System - K033669 * Smith & Nephew Bone Plate System (TC-1O0 Plating and Screw System) - K993106 Page 1of 1 DEPARTME… | 1999 |
What descends from it? (501)
See all 5016 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 |
| K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System | 2014 | 46 |
| K162078 | EVOS Small Fragment Plating System | 2016 | 26 |
| K173293 | EVOS Small Fragment Upper Extremity Plates | 2018 | 12 |
| 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 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2017 | Class II | Z-1854-2017 | Labeling Change Control | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. |
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 8 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 9 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?
PERI-LOC Periarticular Locked Plating System B-Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured B-Plates and Screws are indicated for partial articular fractures of the distal fibula, distal tibia, and proximal tibia. PERI-LOC Locking Tubular Plates are indicated for fracture fixation of the tibia, fibula, femur, 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/K062216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062216: Peri-Loc Periarticular Locked Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062216
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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