510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Locking Proximal Plating (L-PTP) System

K002361510(k) TraditionalCleared Oct 31, 200089-day reviewClass II21 CFR 888.3030

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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Oct 31, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 703 devices in its family, counting itself, has a Class I recall. 702 later devices descend from it.

Decided
Oct 31, 2000
Review
89 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

702 later devices descend from it, 3 citing it directly. 1 of the 703 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2014: 38 descendants cleared2001: 1 descendant cleared2003: 1 descendant cleared2026: 73 descendants cleared2016: 30 descendants cleared2012: 20 descendants cleared2004: 1 descendant cleared2025: 59 descendants cleared2018: 32 descendants cleared2019: 36 descendants cleared2015: 39 descendants cleared2017: 51 descendants cleared2022: 41 descendants cleared2010: 11 descendants cleared2009: 9 descendants cleared2005: 2 descendants cleared2020: 41 descendants cleared2007: 3 descendants cleared2006: 5 descendants cleared2008: 5 descendants cleared2011: 14 descendants cleared2021: 48 descendants cleared, 1 with a Class I recall12023: 51 descendants cleared2024: 66 descendants cleared2013: 25 descendants cleared200020052010201520202025
  1. This deviceK002361 Synthes (Usa) Locking Proximal Plating (L-PTP) SystemSynthes (Usa) · 2000
  2. Descendant · cites it directly · 701 of its ownK011978 Synthes LCP Proximal Tibia PlateSynthes (Usa) · 2001
  3. Descendant · 2 generations on · 690 of its ownK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
  4. Descendant · 3 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  5. Descendant · 3 generations on · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
  6. Descendant · 3 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007

Showing 5 of 702 descendants. See all descendants

Descendants cleared per year

2001: 12003: 12004: 12005: 22006: 52007: 32008: 52009: 92010: 112011: 142012: 202013: 252014: 382015: 392016: 302017: 512018: 322019: 362020: 412021: 482022: 412023: 512024: 662025: 592026: 73
2001high 73 (2026) · low 0 (2002)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 702 · See all
  • K011978Synthes LCP Proximal Tibia PlateSynthes (Usa) · 2001 · cites it directly701descendants
  • K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc. · 2003 · 2 generations on690descendants
  • K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 3 generations on584descendants
  • K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · 3 generations on501descendants
  • K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 3 generations on495descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002361Synthes (Usa) Locking Proximal Plating (L-PTP) SystemSynthes (Usa)2000—
+1K011978Synthes LCP Proximal Tibia PlateSynthes (Usa)2001—
+2K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20031
+3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
+3K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.20061
+3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200410
200520
200650
200730
200850
200990
2010110
2011140
2012200
2013250
2014380
2015390
2016300
2017510
2018320
2019360
2020410
2021481
2022410
2023510
2024660
2025590
2026730
FIG. 1 — Lineage of K002361, 2000–2026Source: 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), 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. #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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (702)

See all 702

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

NumberDeviceApplicantDecidedDescendants
K011978Synthes LCP Proximal Tibia PlateSynthes (Usa)2001701
K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141
K140098Emerge Medical Small Fragment Locked Plating SystemEmerge Medical20140

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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K011978 (Synthes (Usa), 2001) has gone furthest, with 701 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K002361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002361: Synthes (Usa) Locking Proximal Plating (L-PTP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002361

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026