510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Peri-Loc Bone Plating and Screw System

K083032510(k) TraditionalCleared Jan 7, 200989-day reviewClass II21 CFR 888.3030Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · HRS Plate, Fixation, Bone

Cleared on Jan 7, 2009 as substantially equivalent to K082516 (Smith & Nephew, Inc., 2008) and 8 other predicates after an 89-day review. Its family tree reaches back 9 generations to 1996. 77 later devices descend from it. It has been recalled 2 times.

Decided
Jan 7, 2009
Review
89 days
Class
Class II
Product code
HRS
Recalls
2
Predicates
9

Its longest line of descent runs back 9 generations to K962616 (1996). 41 ancestors in all, the oldest K890939 (1989). 77 later devices descend from it, 12 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2003: 2 other ancestors2001: 5 other ancestors2000: 7 other ancestors1999: 3 other ancestors2006: 1 other ancestor2005: 2 other ancestors2004: 3 other ancestors1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestor2016: 4 descendants cleared2014: 7 descendants cleared2017: 5 descendants cleared2022: 5 descendants cleared2021: 4 descendants cleared2013: 1 descendant cleared2018: 4 descendants cleared2023: 11 descendants cleared2019: 1 descendant cleared2015: 3 descendants cleared2020: 2 descendants cleared2025: 11 descendants cleared2024: 13 descendants cleared2026: 6 descendants clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K082516 · Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws · Smith & Nephew, Inc. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 11 other ancestors3 generations back: 12 other ancestors4 generations back: 1 other ancestor6 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 12 descendants2 generations forward: 23 descendants3 generations forward: 18 descendants4 generations forward: 12 descendants5 generations forward: 9 descendants6 generations forward: 3 descendants K082516 · Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws · Smith & Nephew, Inc. · 2008K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50+5
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 5 generations between
  3. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  4. 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  5. 1 generation backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  6. This deviceK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009
  7. Descendant · cites it directly · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  8. Descendant · cites it directly · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  9. Descendant · 2 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  10. Descendant · cites it directly · 26 of its ownK141121 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014
  11. Descendant · 2 generations on · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
Show all 9 generations
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 1 generation backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. This deviceK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2013: 12014: 72015: 32016: 42017: 52018: 42019: 12020: 22021: 42022: 52023: 112024: 132025: 112026: 6
2013high 13 (2024) · low 1 (2013)2026

Most influential descendants

Showing 5 of 77 · See all
  • K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · cites it directly46descendants
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly33descendants
  • K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on32descendants
  • K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014 · cites it directly26descendants
  • K153379AxSOS 3TiStryker GmbH · 2016 · 2 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−8K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−7K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−6K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−2K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−1K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
0 (this device)K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009—
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+1K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+1K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG2014—
+2K153379AxSOS 3TiStryker GmbH2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199110
199510
199610
199820
199930
200070
200150
200210
200320
200430
200520
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201470
201530
201640
201750
201840
201910
202020
202140
202250
2023110
2024130
2025110
202660
FIG. 1 — Lineage of K083032, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws
Summary page 1
…ing and Screw System represents titanium versions of stainless steel PERI- LOCTM Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOCT M Bone Plating and Screw System devices feature various…
Smith & Nephew, Inc.2008—
*K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access
Summary page 1
…ons for use. * PERI-LOCTM Periarticular Locked Plating System - Hexalobular Bone Screws (K082516) * PERI-LOCTM Periarticular Locked Plating System - Proximal Femur (K072818) * PERI-LOCTM Periarticular Locked Plating System - Locking Bone Plates & Screws for the Upper Extremity (K061352) * PERI…
Smith & Nephew, Inc.2007—
*K061352Peri-Loc Periarticular Locked Plating System for the Upper Extremity
Summary page 1
…crew System represents titanium versions of stainless steel PERI- LOCTM Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOCT M Bone Plating and Screw System devices feature various lengths…
Smith & Nephew, Inc.2006—
*K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Summary page 1
…em represents titanium versions of stainless steel PERI- LOCTM Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOCT M Bone Plating and Screw System devices feature various lengths of straig…
Smith & Nephew, Inc.2005—
*K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)
Summary page 1
…titanium versions of stainless steel PERI- LOCTM Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOCT M Bone Plating and Screw System devices feature various lengths of straight and contou…
Smith & Nephew, Inc.20031
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 1
…ocking Bone Plates and Locking Bone Screws for the Upper Extremity (K051735) * Smith & Nephew Locking Bone Plate System (K033669) * Smith & Nephew Bone Plate System (K993106) · Synthes Large Fragment DCL System (K000682) * Synthes Small Fragment DCL System (K000684) * Synthes LCP Proximal Humerus…
Smith & Nephew, Inc.1999—
*K000682Synthes Large Fragment Dynamic Compression Locking (DCL) System
Summary page 1
…he Upper Extremity (K051735) * Smith & Nephew Locking Bone Plate System (K033669) * Smith & Nephew Bone Plate System (K993106) · Synthes Large Fragment DCL System (K000682) * Synthes Small Fragment DCL System (K000684) * Synthes LCP Proximal Humerus Plate (K011815)…
Synthes (Usa)2000—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 1
…Locking Bone Plate System (K033669) * Smith & Nephew Bone Plate System (K993106) · Synthes Large Fragment DCL System (K000682) * Synthes Small Fragment DCL System (K000684) * Synthes LCP Proximal Humerus Plate (K011815)…
Synthes (Usa)20001
*K011815Synthes LCP Proximal Humerus Plates
Summary page 1
…ephew Bone Plate System (K993106) · Synthes Large Fragment DCL System (K000682) * Synthes Small Fragment DCL System (K000684) * Synthes LCP Proximal Humerus Plate (K011815) Page 1 of 1 0IC~ DE…
Synthes (Usa)2001—

Also cleared against K082516: 7 other devices →

What descends from it? (77)

See all 77

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.201446
K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333
K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714
K132296D-Rad Smart PackSmith & Nephew, Inc.201411
K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610
K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20217
K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.20222
K173121Ankle Fusion Plating SystemIn2bones Sas20172

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 20, 2015Class IIZ-0373-2016Employee errorThe devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.
Oct 20, 2015Class IIZ-0372-2016Employee errorThe devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
  • 9 of the 41 ancestors have a recall of any class.
  • Of its descendants, K132886 (Smith & Nephew, Inc., 2014) has gone furthest, with 46 descendants of its own.
  • 7 other devices also cite its predicate K082516.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The PERI-LOC TM Bone Plating and Screw System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC TM 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 TM Bone Plating and Screw System are for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K082516

7 other devices cite the same predicate.

  • K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip…Smith & Nephew, Inc. · 20221 recall
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 20211 recall
  • K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 20161 recall
  • K161665VLP Wrist Fracture SystemSmith & Nephew, Inc. · 2016
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K083032 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083032: Peri-Loc Bone Plating and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083032

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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