510(k) · Cleared
ClearedSynthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone
Cleared on Oct 8, 2013 as substantially equivalent to K111230 (Synthes (USA) Products, LLC, 2011) and 4 other predicates after a 166-day review. Its family tree reaches back 7 generations to 2000. 8 later devices descend from it.
- Decided
- Oct 8, 2013
- Review
- 166 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K000684 (2000). 34 ancestors in all, the oldest K890939 (1989). 8 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 1 generation backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- This deviceK131186 Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC · 2013
- Descendant · cites it directly · 4 of its ownK233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT…DePuy Synthes · 2024
- Descendant · 2 generations on · 0 of its ownK254093 DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK260069 DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK252191 BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
- Descendant · 2 generations on · 0 of its ownK251361 Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes · 2024 · cites it directly4descendants
- K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH · 2026 · 2 generations on0descendants
- K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH · 2026 · 2 generations on0descendants
- K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025 · 2 generations on0descendants
- K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −3 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −2 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −1 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K131186 | Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System | Synthes (USA) Products, LLC | 2013 | — |
| +1 | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small… | DePuy Synthes | 2024 | — |
| +2 | K254093 | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | Synthes GmbH | 2026 | — |
| +2 | K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | Synthes GmbH | 2026 | — |
| +2 | K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | 2025 | — |
| +2 | K251361 | Tyber Medical Distal Radius Plating System | Tyber Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K012583 | FDA’s K012583 is Acuglide Brand Acupuncture Needles Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K111230 | Synthes 3.5MM Low Profile Cortical Screw | 2011 |
| * | K103705 | Low Profile ScrewsSummary page 1…vynthes Contical Screws (K] 12583) Prediate ynthes 3.5mm Low Profile Cortical Screws (KI 11230) Predicaterthrex Low Profile Screws (K 103705) Device(s): yntthes Locking Calcaneal Plates (K991407) Synthes 2.4/2.7 VA LCP Forefoot/Midfoot Syst… | 2011 |
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 1…Prediate ynthes 3.5mm Low Profile Cortical Screws (KI 11230) Predicaterthrex Low Profile Screws (K 103705) Device(s): yntthes Locking Calcaneal Plates (K991407) Synthes 2.4/2.7 VA LCP Forefoot/Midfoot System (K]00776) Synihes 2.4mm/2.7mm Locki… | 1999 |
| Kept off the family tree | K100776 | FDA’s K100776 is Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K071264 | Synthes (Usa) 2.4/2.7 MM Locking Foot ModuleSummary page 1…alcaneal Plates (K991407) Synthes 2.4/2.7 VA LCP Forefoot/Midfoot System (K]00776) Synihes 2.4mm/2.7mm Locking Talus Plate (K07 1264) Stryker Foot Plating System (K063875) 47… | 2007 |
| * | K063875 | Stryker Foot Plating SystemSummary page 1….7 VA LCP Forefoot/Midfoot System (K]00776) Synihes 2.4mm/2.7mm Locking Talus Plate (K07 1264) Stryker Foot Plating System (K063875) 47 K 131 186 page 2 of 2 Th… | 2007 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment… | 2024 | 4 |
| K223150 | APS Metal Plate & Screw System | 2023 | 0 |
| K190992 | OrthoPediatrics PediFoot Deformity Corrections System | 2019 | 0 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 | 0 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 34 ancestors have a recall of any class.
- Of its descendants, K233665 (DePuy Synthes, 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K111230.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
The Synthes 2.7 and 3.5 mm Variable Angle LCP Midfoot/Hindfoot 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. The Synthes 3.5mm Low Profile Cortical Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for…
Read the full statement (201 words)
The Synthes 2.7 and 3.5 mm Variable Angle LCP Midfoot/Hindfoot 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.
The Synthes 3.5mm Low Profile Cortical Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The Synthes 3.5mm Cortex Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131186: Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131186
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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