510(k) · Cleared
ClearedSmall and Large Fragments Osteosynthesis System Neofix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoortho Produtos Ortopedicos S/A · HRS Plate, Fixation, Bone
Cleared on Mar 23, 2012 as substantially equivalent to K012655 (Acu Med, Inc., 2001) and 18 other predicates after a 95-day review. Its family tree reaches back 5 generations to 1998. 11 later devices descend from it.
- Decided
- Mar 23, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 22
Its longest line of descent runs back 5 generations to K981372 (1998). 40 ancestors in all, the oldest K882831 (1988). 11 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 1 generation backK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- This deviceK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
- Descendant · cites it directly · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
- Descendant · 2 generations on · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
- Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · 2 generations on · 2 of its ownK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
- Descendant · 2 generations on · 1 of its ownK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · cites it directly8descendants
- K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019 · 2 generations on4descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
- K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · 2 generations on2descendants
- K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | 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 | — |
| 0 (this device) | K113733 | Small and Large Fragments Osteosynthesis System Neofix | Neoortho Produtos Ortopedicos S/A | 2012 | — |
| +1 | K142419 | Mini and Micro Fragments Reconstruction System-NEOFIX | Neoortho Productos Orthopedicos S/A | 2014 | — |
| +2 | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | Gm Dos Reis Industria E Comerico Ltda. | 2019 | — |
| +2 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +2 | K242596 | Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. | 2024 | — |
| +2 | K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (22)
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 |
|---|---|---|---|
| * | K012655 | Congruent Bone Plate SystemSummary page 2…m NEOFIX is substantially equivalent in indications and design principles to the following predicate devices. PredicateKNubrCmayNmDeieae NumberKNubrCmayNmDeieae I K012655 Acumed. Inc. Congruent Bone Plate System 2 K071715 Acumed. Inc Acumed Congruent… | 2001 |
| * | K071715 | Acumed Congruent Bone Plate SystemSummary page 2…ollowing predicate devices. PredicateKNubrCmayNmDeieae NumberKNubrCmayNmDeieae I K012655 Acumed. Inc. Congruent Bone Plate System 2 K071715 Acumed. Inc Acumed Congruent Bone Plate System 3 K04 1860 Synthes (USA) Synthes (USA)… | 2007 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 2…I K012655 Acumed. Inc. Congruent Bone Plate System 2 K071715 Acumed. Inc Acumed Congruent Bone Plate System 3 K04 1860 Synthes (USA) Synthes (USA) LCP ' Proximal Humerus Plates, long 4 K0t 1815 Synthes (USA)… | 2004 |
| Kept off the family tree | K071815 | FDA’s K071815 is Noveon, Model LS1100-01-0968 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
| * | K101421 | Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…Summary page 2…(USA) Synthes (USA) LCP ' Proximal Humerus Plates, long 4 K0t 1815 Synthes (USA) Synthes LCP Proximal Humerus Plates 5 K<101421 DePuy Orthopaedics. Inc DePuy Anatomic Locked Plating System Long Plate Line Extension 6 K00684Syntes (SA)Sy… | 2010 |
| Kept off the family tree | K000684 | FDA’s K000684 is Small Fragment Dynamic Compression Locking (DCL) System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 2…Syntes (SA)Synthes (USA) Small Fragment Dynamic Compression Locking (DCL) 6 Syntes (SA)System K00684 7 K01 1335 Synthes (USA) Synthes One-Third Tubular Plate 8 K000558 Synthes (USA) Synthes (USA) Wris… | 2001 |
| * | K000558 | Synthes (Usa) Wrist Fusion Plates (WFP)Summary page 2…(DCL) 6 Syntes (SA)System K00684 7 K01 1335 Synthes (USA) Synthes One-Third Tubular Plate 8 K000558 Synthes (USA) Synthes (USA) Wrist Fusion Plates (WFP) 9 K020401 Synthes (USA). Synthes C… | 2000 |
| * | K020401 | Synthes Calcaneal PlateSummary page 2…1 1335 Synthes (USA) Synthes One-Third Tubular Plate 8 K000558 Synthes (USA) Synthes (USA) Wrist Fusion Plates (WFP) 9 K020401 Synthes (USA). Synthes Calcaneal Plate 10 K020602 Synthes (USA) Synthes Pilon Plate 11… | 2002 |
| * | K020602 | Synthes Pilon PlateSummary page 2…K000558 Synthes (USA) Synthes (USA) Wrist Fusion Plates (WFP) 9 K020401 Synthes (USA). Synthes Calcaneal Plate 10 K020602 Synthes (USA) Synthes Pilon Plate 11 K023802 Synthes (USA) Synthes (USA) 4.5 mm Titanium… | 2002 |
| * | K023802 | Synthes 4.5 MM Titanium LCP Proximal Tibia Plating SystemSummary page 2…Plates (WFP) 9 K020401 Synthes (USA). Synthes Calcaneal Plate 10 K020602 Synthes (USA) Synthes Pilon Plate 11 K023802 Synthes (USA) Synthes (USA) 4.5 mm Titanium LCP Proximal Tibia Plating System 12 K092609 Synthes (USA… | 2003 |
| * | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Summary page 2…nthes (USA) Synthes Pilon Plate 11 K023802 Synthes (USA) Synthes (USA) 4.5 mm Titanium LCP Proximal Tibia Plating System 12 K092609 Synthes (USA) Synthes 3.5 mm and 4.5 mmn Curved Narrow and Broad Locking 12… | 2009 |
| Kept off the family tree | K061376 | FDA’s K061376 is EL-Anca: Anti-Mpo, Anti-PR3, Anti-Mpo and Anti-PR3 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K081353 | Synthes (Usa) Tomofix Medial Distal Femur PlatesSummary page 2…Synthes (USA) Large Fragment Locking Compression Plate (LCP) S y ste m - I Pla te I3 K 10 6 14 K08 1353 Synthes (USA) Synthes (USA) TomoFiXTM Medial Distal Femur Plates… | 2008 |
| * | K023941 | Synthes Tomofix Osteotomy SystemSummary page 3…(31 3) Predicate K Number Company Name Device Name Number 15 K023941 Synthes (USA) Synthes (USA) TomoFix T" Osteotomy System 16 K000089 Synthes (USA) Synthes 4.0 and 50 mm… | 2003 |
| * | K000089 | Synthes 4.0 and 5.0 MM Locking ScrewsSummary page 3…(31 3) Predicate K Number Company Name Device Name Number 15 K023941 Synthes (USA) Synthes (USA) TomoFix T" Osteotomy System 16 K000089 Synthes (USA) Synthes 4.0 and 50 mm Locking Screws 17 K04 1533 Synthes (USA) Peni-Prosthetic Screws… | 2000 |
| * | K041533 | Synthes (Usa) [Synthes} Peri-Prosthetic ScrewsSummary page 3…K023941 Synthes (USA) Synthes (USA) TomoFix T" Osteotomy System 16 K000089 Synthes (USA) Synthes 4.0 and 50 mm Locking Screws 17 K04 1533 Synthes (USA) Peni-Prosthetic Screws I8 K033995 Synthes (USA) Synthes (USA) 3.5 mm LCP Distal Humerus S… | 2004 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 3…tomy System 16 K000089 Synthes (USA) Synthes 4.0 and 50 mm Locking Screws 17 K04 1533 Synthes (USA) Peni-Prosthetic Screws I8 K033995 Synthes (USA) Synthes (USA) 3.5 mm LCP Distal Humerus System 19 K043 185 Synthes (USA) Synthes (USA) 3.… | 2004 |
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 3…s 17 K04 1533 Synthes (USA) Peni-Prosthetic Screws I8 K033995 Synthes (USA) Synthes (USA) 3.5 mm LCP Distal Humerus System 19 K043 185 Synthes (USA) Synthes (USA) 3.5 mm Cortex Screws 20 K961413 Synthes (USA) Synthes Anatomical Locking Pl… | 2005 |
| * | K961413 | Synthes Anatomical Locking Plate SystemSummary page 3…K033995 Synthes (USA) Synthes (USA) 3.5 mm LCP Distal Humerus System 19 K043 185 Synthes (USA) Synthes (USA) 3.5 mm Cortex Screws 20 K961413 Synthes (USA) Synthes Anatomical Locking Plate System 21 K061621 Synthes (USA) Synthes (USA) 6.5 mm Ca… | 1996 |
| * | K061621 | Synthes (Usa) 6.5 MM Cancellous ScrewsSummary page 3…19 K043 185 Synthes (USA) Synthes (USA) 3.5 mm Cortex Screws 20 K961413 Synthes (USA) Synthes Anatomical Locking Plate System 21 K061621 Synthes (USA) Synthes (USA) 6.5 mm Cantcellous Screws 22 K03 1573 Synthes (USA) Synthes 3.5 mm Low Prof… | 2006 |
| * | K031573 | Synthes 3.5 MM Low Profile Pelvic Reconstruction PlateSummary page 3…K961413 Synthes (USA) Synthes Anatomical Locking Plate System 21 K061621 Synthes (USA) Synthes (USA) 6.5 mm Cantcellous Screws 22 K03 1573 Synthes (USA) Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate The subject device and the predicate devices have… | 2003 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 40 ancestors have a recall of any class.
- Of its descendants, K142419 (Neoortho Productos Orthopedicos S/A, 2014) has gone furthest, with 8 descendants of its own.
- 27 other devices also cite its predicate K012655.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Small and Large Fragments Osteosynthesis System NEOFIX is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, carpals, metacarpals, distal femur, proximal tibia, tibial pilon, fibula, calcaneus, tarsals and metatarsals; small fragments of the hand and wrist; pelvis and acetabulum fractures; periprosthetic fractures; metatarsal and phalangeal osteotomies; and carpal, metacarpal, wrist and ankle arthrodesis. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113733: Small and Large Fragments Osteosynthesis System Neofix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113733
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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