510(k) · Cleared
ClearedSynthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Nov 24, 2008 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 4 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1998. 186 later devices descend from it.
- Decided
- Nov 24, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K981372 (1998). 11 ancestors in all. 186 later devices descend from it, 43 citing it directly.
- Root · 3 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 2 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 1 generation backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- This deviceK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- Descendant · cites it directly · 51 of its ownK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- Descendant · cites it directly · 27 of its ownK130009 Variax 2 Compression Plating SystemStryker Trauma AG · 2013 · Recalled
- Descendant · 2 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
- Descendant · 3 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 186 · See all- K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa) · 2009 · cites it directly51descendants
- K130009Variax 2 Compression Plating SystemStryker Trauma AG · 2013 · cites it directly27descendants
- K132502Variax 2 SystemStryker Trauma AG · 2013 · 2 generations on21descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
- K140769Variax 2 SystemStryker Trauma AG · 2014 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −2 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| 0 (this device) | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| +1 | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… | Synthes (Usa) | 2009 | — |
| +1 | K130009 | Variax 2 Compression Plating System | Stryker Trauma AG | 2013 | 1 |
| +2 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| +1 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
| +3 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 13 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 16 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 16 | 0 |
| 2024 | 23 | 0 |
| 2025 | 18 | 0 |
| 2026 | 17 | 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? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 4…3030; Singlelmultiple component metallic bone fixation appliances and accessories. Predicate Devices: Smith & Nephew Locking Bone Plate System (K033669) Smith & Nephew Bone Plate System (K9931 06) Synthes Locking Compression Plates (K000… | 2003 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 4…fixation appliances and accessories. Predicate Devices: Smith & Nephew Locking Bone Plate System (K033669) Smith & Nephew Bone Plate System (K9931 06) Synthes Locking Compression Plates (K000682, K000684, K041911) Device Description: Synthes 3.5 mm and 4… | 1999 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…& Nephew Locking Bone Plate System (K033669) Smith & Nephew Bone Plate System (K9931 06) Synthes Locking Compression Plates (K000682, K000684, K041911) Device Description: Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications co… | 2000 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…Locking Bone Plate System (K033669) Smith & Nephew Bone Plate System (K9931 06) Synthes Locking Compression Plates (K000682, K000684, K041911) Device Description: Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist on.… | 2000 |
| * | K041911 | Synthes (Usa) LCP Curved PlatesSummary page 4…Bone Plate System (K033669) Smith & Nephew Bone Plate System (K9931 06) Synthes Locking Compression Plates (K000682, K000684, K041911) Device Description: Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist on.5 mm LCP… | 2004 |
What descends from it? (186)
See all 18643 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) | 2009 | 51 |
| K130009 | Variax 2 Compression Plating System | 2013 | 27 |
| K162674 | BioPro Foot Plating Systems | 2017 | 19 |
| K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | 2010 | 18 |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | 2016 | 15 |
| K102597 | Piccolo Composite Plate System | 2011 | 15 |
| K123562 | Flower Small and Medium Bone Implants | 2013 | 14 |
| K131657 | Flower Small and Medium Implant Set | 2013 | 11 |
| K130061 | Piccolo Composite Plate System | 2013 | 10 |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE… | 2023 | 7 |
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 10 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K092609 (Synthes (Usa), 2009) has gone furthest, with 51 descendants of its own.
- 27 other devices also cite its predicate K033669.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The Synthes 4.5 mm Locking Compression Plate (LCP) System is…
Read the full statement (118 words)
The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
The Synthes 4.5 mm Locking Compression Plate (LCP) System is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082807
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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