510(k) Report

510(k) · Cleared

Cleared

Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System

K100776510(k) TraditionalCleared Aug 3, 2010138-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 Aug 3, 2010 as substantially equivalent to K071264 (Synthes (Usa), 2007) and 6 other predicates after a 138-day review. Its family tree reaches back 9 generations to 1996. 228 later devices descend from it.

Decided
Aug 3, 2010
Review
138 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
7

Its longest line of descent runs back 9 generations to K962616 (1996). 78 ancestors in all, the oldest K792022 (1979). 228 later devices descend from it, 26 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 2 other ancestors2008: 2 other ancestors2007: 2 other ancestors2006: 6 other ancestors2005: 4 other ancestors2003: 3 other ancestors2002: 3 other ancestors2001: 8 other ancestors1996: 6 other ancestors2004: 4 other ancestors2000: 8 other ancestors1999: 3 other ancestors1992: 1 other ancestor1990: 1 other ancestor1998: 3 other ancestors1994: 4 other ancestors1993: 2 other ancestors1979: 1 other ancestor1995: 2 other ancestors1991: 1 other ancestor1989: 1 other ancestor1997: 1 other ancestor2015: 15 descendants cleared2019: 12 descendants cleared2012: 6 descendants cleared2023: 20 descendants cleared2021: 20 descendants cleared2024: 32 descendants cleared2017: 17 descendants cleared2018: 8 descendants cleared2013: 2 descendants cleared2011: 1 descendant cleared2020: 17 descendants cleared2014: 5 descendants cleared2025: 19 descendants cleared2016: 5 descendants cleared2022: 17 descendants cleared2026: 32 descendants clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 12 other ancestors3 generations back: 15 other ancestors4 generations back: 18 other ancestors5 generations back: 11 other ancestors6 generations back: 4 other ancestors7 generations back: 1 other ancestor8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 26 descendants2 generations forward: 78 descendants3 generations forward: 66 descendants4 generations forward: 31 descendants5 generations forward: 18 descendants6 generations forward: 5 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · 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 backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  5. 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  6. This deviceK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  7. Descendant · cites it directly · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  8. Descendant · cites it directly · 76 of its ownK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  9. Descendant · cites it directly · 53 of its ownK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
  10. Descendant · cites it directly · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  11. Descendant · 2 generations on · 33 of its ownK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
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 backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. This deviceK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010

Showing 5 of 228 descendants. See all descendants

Descendants cleared per year

2011: 12012: 62013: 22014: 52015: 152016: 52017: 172018: 82019: 122020: 172021: 202022: 172023: 202024: 322025: 192026: 32
2011high 32 (2024) · low 1 (2011)2026

Most influential descendants

Showing 5 of 228 · See all
  • K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · cites it directly118descendants
  • K120070Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · cites it directly76descendants
  • K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA · 2012 · cites it directly53descendants
  • K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · cites it directly44descendants
  • K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC · 2017 · 2 generations on33descendants
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—
−2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
0 (this device)K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
+1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
+1K120070Synthes Variable Angle LCP Elbow SystemSynthes USA20121
+1K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal…Synthes USA2012—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
+2K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated…Synthes USA Products, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199010
199110
199210
199320
199440
199520
199660
199710
199830
199930
200080
200180
200230
200330
200440
200540
200660
200720
200820
200920
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201260
201320
201450
2015150
201650
2017170
201880
2019120
2020170
2021200
2022170
2023200
2024320
2025190
2026320
FIG. 1 — Lineage of K100776, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (7)

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
*K071264Synthes (Usa) 2.4/2.7 MM Locking Foot ModuleSynthes (Usa)2007—
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 1
…nd accessories. Predicate Device: Synthes 2.4 mm / 2.7 mm Locking Foot Module (KO7 1264) Synthes Modular Mini Fragment LCP System (K063049) DARCO Locking Bone Plate System (K061808) Merete Locking Bone Plate Syst…
Synthes (Usa)20064
*K061808Darco Locking Bone Plate System
Summary page 1
…ocking Foot Module (KO7 1264) Synthes Modular Mini Fragment LCP System (K063049) DARCO Locking Bone Plate System (K061808) Merete Locking Bone Plate System (K090063) OrthoHelix Surgical Designs,…
Darco International, Inc.20063
*K090063Merete Locking Bone Plate System
Summary page 1
…ar Mini Fragment LCP System (K063049) DARCO Locking Bone Plate System (K061808) Merete Locking Bone Plate System (K090063) OrthoHelix Surgical Designs, Inc. MaxL-ock ExtremeTm Extremity Plating S…
Merete Medical, Inc.2009—
*K100618Maxlock Extreme Extremity Plating System with Variable Angle Technology
Cleared while this submission was under review
Summary page 1
…63) OrthoHelix Surgical Designs, Inc. MaxL-ock ExtremeTm Extremity Plating System with Variable Angle Technology (K 100618) OrthoHelix Surgical Designs, Inc. Modular Foot System (K(073624) Smith &…
Orthohelix Surgical Designs, Inc.2010—
*K073624Modular Foot System
Summary page 1
…Plating System with Variable Angle Technology (K 100618) OrthoHelix Surgical Designs, Inc. Modular Foot System (K(073624) Smith & Nephew VLP Foot Plating System (K090675) Device Description: The Synthes 2.4/2.7 mm…
Orthohelix Surgical Designs, Inc.20081
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 1
…100618) OrthoHelix Surgical Designs, Inc. Modular Foot System (K(073624) Smith & Nephew VLP Foot Plating System (K090675) Device Description: The Synthes 2.4/2.7 mm Variable Angle LCP Forefoot / Midfoot System con…
Smith & Nephew, Inc.2009—

Also cleared against K071264: 10 other devices →

What descends from it? (228)

See all 228

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

NumberDeviceApplicantDecidedDescendants
K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118
K120070Synthes Variable Angle LCP Elbow SystemSynthes USA201276
K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253
K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244
K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited201428
K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH201324
K140376Variax 2 SystemStryker Trauma AG201423
K142581APTUS Foot SystemMedartis AG201522
K162674BioPro Foot Plating SystemsBiopro, Inc.201719
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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 18 of the 78 ancestors have a recall of any class.
  • Of its descendants, K112583 (Synthes (USA) Products, LLC, 2011) has gone furthest, with 118 descendants of its own.
  • 10 other devices also cite its predicate K071264.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

Also cleared against K071264

10 other devices cite the same predicate.

  • K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC · 2021
  • K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes · 2019
  • K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG · 2019
  • K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and…Meril Healthcare Pvt., Ltd. · 2018
  • K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc. · 2015
  • K142581APTUS Foot SystemMedartis AG · 2015

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/K100776 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100776

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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