510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Synthes (Usa) Modular Mini Fragment LCP System

K063049510(k) TraditionalCleared Dec 18, 200675-day reviewClass II21 CFR 888.3030Recalls 4

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 Dec 18, 2006 after a 75-day review. The FDA summary names its predicate without a number. 468 later devices descend from it. It has been recalled 4 times.

Decided
Dec 18, 2006
Review
75 days
Class
Class II
Product code
HRS
Recalls
4
Predicates
0

468 later devices descend from it, 40 citing it directly.

Descendants, by year cleared 2022: 37 descendants cleared2010: 3 descendants cleared2011: 8 descendants cleared2023: 38 descendants cleared2012: 15 descendants cleared2015: 29 descendants cleared2025: 37 descendants cleared2014: 22 descendants cleared2019: 26 descendants cleared2021: 32 descendants cleared2026: 49 descendants cleared2017: 38 descendants cleared2018: 22 descendants cleared2024: 51 descendants cleared2020: 36 descendants cleared2013: 11 descendants cleared2016: 14 descendants cleared20052010201520202025
  1. This deviceK063049 Synthes (Usa) Modular Mini Fragment LCP SystemSynthes (Usa) · 2006
  2. Descendant · cites it directly · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  3. Descendant · cites it directly · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
  4. Descendant · cites it directly · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
  5. Descendant · 2 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  6. Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011

Showing 5 of 468 descendants. See all descendants

Descendants cleared per year

2010: 32011: 82012: 152013: 112014: 222015: 292016: 142017: 382018: 222019: 262020: 362021: 322022: 372023: 382024: 512025: 372026: 49
2010high 51 (2024) · low 3 (2010)2026

Most influential descendants

Showing 5 of 468 · See all
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · cites it directly228descendants
  • K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · cites it directly135descendants
  • K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · cites it directly119descendants
  • K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 2 generations on118descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K063049Synthes (Usa) Modular Mini Fragment LCP SystemSynthes (Usa)2006—
+1K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
+1K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011—
+1K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101
+2K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
+2K112437Arthrex Fracture SystemArthrex, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201180
2012150
2013110
2014220
2015290
2016140
2017380
2018220
2019260
2020360
2021320
2022370
2023380
2024510
2025370
2026490
FIG. 1 — Lineage of K063049, 2006–2026Source: 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? (3)

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
*—Synthes Stainless Steel Modular Hand System
Named without a submission number
—
*—Synthes Modular Foot System
Named without a submission number
—
*—Synthes Modular Foot System- 2.7 mm Module
Named without a submission number
—

What descends from it? (468)

See all 468

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

NumberDeviceApplicantDecidedDescendants
K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228
K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135
K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.2010119
K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201085
K103332Aptus Ulna PlatesMedartis AG201171
K123000Integra Total Foot SystemsIntegra LifeSciences Corporation201254
K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.201446
K143394Acumed Small Fragment Base SetAcumed, LLC201518
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714
K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 28, 2016Class IIZ-2389-2016Nonconforming Material/ComponentIt was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature…
Nov 2, 2015Class IIZ-0323-2016Process controlIt was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment…
Oct 6, 2015Class IIZ-0167-2016PackagingSpecific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Jul 31, 2013Class IIZ-0380-2014Labeling mix-upsSpecific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K100776 (Synthes (Usa), 2010) has gone furthest, with 228 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—

What is it indicated for?

The Synthes (USA) Modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

Indications for use as stated in the FDA summary.

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/K063049 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063049: Synthes (Usa) Modular Mini Fragment LCP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063049

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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