510(k) Report

510(k) · Cleared

Cleared

Signex

K243469510(k) TraditionalCleared May 29, 2025202-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

Osteonic Co., Ltd. · HRS Plate, Fixation, Bone

Cleared on May 29, 2025 as substantially equivalent to K230546 (Osteonic Co., Ltd., 2024) and 22 other predicates after a 202-day review. Its family tree reaches back 11 generations to 1996.

Decided
May 29, 2025
Review
202 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
23

Its longest line of descent runs back 11 generations to K962616 (1996). 176 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2024: 1 other ancestor2014: 1 other ancestor2012: 1 other ancestor2011: 8 other ancestors2010: 4 other ancestors2009: 8 other ancestors2008: 6 other ancestors2006: 9 other ancestors2005: 11 other ancestors2004: 11 other ancestors2001: 16 other ancestors2000: 9 other ancestors2013: 1 other ancestor2007: 3 other ancestors2003: 9 other ancestors1999: 7 other ancestors1996: 16 other ancestors2002: 7 other ancestors1998: 7 other ancestors1995: 6 other ancestors1991: 1 other ancestor1989: 2 other ancestors1992: 2 other ancestors1990: 3 other ancestors1997: 5 other ancestors1994: 7 other ancestors1993: 3 other ancestors1979: 1 other ancestorK962616 · 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. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K112583 · Synthes Cortical Screws · Synthes (USA) Products, LLC · 201119801990200020102020
Other ancestors, by generation 1 generation back: 22 other ancestors2 generations back: 22 other ancestors3 generations back: 20 other ancestors4 generations back: 23 other ancestors5 generations back: 27 other ancestors6 generations back: 22 other ancestors7 generations back: 18 other ancestors8 generations back: 8 other ancestors9 generations back: 3 other ancestors K112583 · Synthes Cortical Screws · Synthes (USA) Products, LLC · 2011K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · 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) · 1996−10−50
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations between
  3. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  4. 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  5. 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  6. This deviceK243469 SignexOsteonic Co., Ltd. · 2025
Show all 11 generations
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  12. This deviceK243469 SignexOsteonic Co., Ltd. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−10K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−9K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−8K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−4K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
0 (this device)K243469SignexOsteonic Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198920
199030
199110
199220
199330
199470
199560
1996160
199750
199870
199970
200090
2001160
200270
200390
2004110
2005110
200690
200730
200860
200980
201040
201180
201210
201310
201410
202410
FIG. 1 — Lineage of K243469, 1996–2025Source: 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? (23)

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
*K230546Signex
Summary page 5
…th or threaded metallic bone fixation fastener (21 CFR 888.3040) Regulatory Class: II Product Code: HRS, HWC 5. Primary Predicate Device 510(k) Number: K230546 Device Name: SIGNEX Manufacturer: OSTEONIC Co., Ltd. 6. Additional Predicate Device  Acumed Congruent Bone Pla…
Osteonic Co., Ltd.2024—
*K102998Congruent Bone Plate System
Summary page 5
…e 510(k) Number: K230546 Device Name: SIGNEX Manufacturer: OSTEONIC Co., Ltd. 6. Additional Predicate Device  Acumed Congruent Bone Plate System (K102998)  APTUS 1.5 TriLock (K102537)  APTUS 2.0 RADIAL HEAD SYSTEM (K090053)  APTUS FOOT 3.5 SYSTEM (K110908)  A…
Acumed, LLC2011—
*K102537Aptus 1.5 Trilock
Summary page 5
…Device Name: SIGNEX Manufacturer: OSTEONIC Co., Ltd. 6. Additional Predicate Device  Acumed Congruent Bone Plate System (K102998)  APTUS 1.5 TriLock (K102537)  APTUS 2.0 RADIAL HEAD SYSTEM (K090053)  APTUS FOOT 3.5 SYSTEM (K110908)  APTUS FOOT SYSTEM (K091479)  A…
Medartis AG2010—
*K090053Aptus 2.0 Radial Head System
Summary page 5
…C Co., Ltd. 6. Additional Predicate Device  Acumed Congruent Bone Plate System (K102998)  APTUS 1.5 TriLock (K102537)  APTUS 2.0 RADIAL HEAD SYSTEM (K090053)  APTUS FOOT 3.5 SYSTEM (K110908)  APTUS FOOT SYSTEM (K091479)  APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567)…
Medartis AG2009—
*K110908Aptus Foot 3.5 System
Summary page 5
…Device  Acumed Congruent Bone Plate System (K102998)  APTUS 1.5 TriLock (K102537)  APTUS 2.0 RADIAL HEAD SYSTEM (K090053)  APTUS FOOT 3.5 SYSTEM (K110908)  APTUS FOOT SYSTEM (K091479)  APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567)  APTUS ULNA PLATES (K103332)…
Medartis AG2011—
*K091479Aptus Foot System
Summary page 5
…Plate System (K102998)  APTUS 1.5 TriLock (K102537)  APTUS 2.0 RADIAL HEAD SYSTEM (K090053)  APTUS FOOT 3.5 SYSTEM (K110908)  APTUS FOOT SYSTEM (K091479)  APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567)  APTUS ULNA PLATES (K103332)  DEPUY SYNTHES TOMOFIX OSTEOTOMY…
Medartis AG20092
*K051567Aptus Titanium Osteosynthesis System
Summary page 5
…537)  APTUS 2.0 RADIAL HEAD SYSTEM (K090053)  APTUS FOOT 3.5 SYSTEM (K110908)  APTUS FOOT SYSTEM (K091479)  APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567)  APTUS ULNA PLATES (K103332)  DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K141796)  SMALL FRAGMENT DYNAMIC COMPRES…
Medartis, Inc.20051
*K103332Aptus Ulna Plates
Summary page 5
…YSTEM (K090053)  APTUS FOOT 3.5 SYSTEM (K110908)  APTUS FOOT SYSTEM (K091479)  APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567)  APTUS ULNA PLATES (K103332)  DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K141796)  SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684)…
Medartis AG2011—
*K141796Depuy Synthes Tomofix Osteotomy System
Summary page 5
… APTUS FOOT SYSTEM (K091479)  APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567)  APTUS ULNA PLATES (K103332)  DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K141796)  SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684)  SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DIS…
Synthes (USA) Products, LLC2014—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 5
…STEM (K051567)  APTUS ULNA PLATES (K103332)  DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K141796)  SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684)  SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694)  SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PRO…
Synthes (Usa)20001
*K083694Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates
Summary page 5
…OTOMY SYSTEM (K141796)  SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684)  SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694)  SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K050646)  SYNTHES (USA) 3.5MM LCP HOOK PLATE (K082072)…
Synthes (Usa)20092
*K050646Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates
Summary page 5
…DCL) SYSTEM (K000684)  SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694)  SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K050646)  SYNTHES (USA) 3.5MM LCP HOOK PLATE (K082072)  SYNTHES (USA) CLAVICLE HOOK PLATES (K061753)  SYNTHES (USA) LCP…
Synthes (Usa)2005—
*K082072Synthes (Usa) 3.5MM LCP Hook Plate
Summary page 5
…-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694)  SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K050646)  SYNTHES (USA) 3.5MM LCP HOOK PLATE (K082072)  SYNTHES (USA) CLAVICLE HOOK PLATES (K061753)  SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG (K041860)  SYNT…
Synthes (Usa)2008—
*K061753Synthes (Usa) Clavicle Hook Plates
Summary page 5
… SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K050646)  SYNTHES (USA) 3.5MM LCP HOOK PLATE (K082072)  SYNTHES (USA) CLAVICLE HOOK PLATES (K061753)  SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG (K041860)  SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K083213)…
Synthes (Usa)2006—
*K041860Synthes (Usa) LCP Proximal Humerus Plates, Long
Summary page 5
…(K050646)  SYNTHES (USA) 3.5MM LCP HOOK PLATE (K082072)  SYNTHES (USA) CLAVICLE HOOK PLATES (K061753)  SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG (K041860)  SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K083213) 1 / 5…
Synthes (Usa)2004—
*K083213Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates
Summary page 5
… SYNTHES (USA) CLAVICLE HOOK PLATES (K061753)  SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG (K041860)  SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K083213) 1 / 5 K243469 === Pag…
Synthes (Usa)2008—
*K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)
Summary page 6
…K243469  SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) (K092609)  SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K111540)  SYNTHES CORTICAL SCREWS (K112583)  SYNTHES LCP DISTAL FEMU…
Synthes (Usa)2009—
*K111540Synthes 3.5MM LCP Clavicle Plate System
Summary page 6
…== Page 6 ===  SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) (K092609)  SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K111540)  SYNTHES CORTICAL SCREWS (K112583)  SYNTHES LCP DISTAL FEMUR PLATES (K062564)  SYNTHES LOCKING DISTAL RADIUS P…
Synthes (Usa)2011—
*K112583Synthes Cortical Screws
Summary page 6
….55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) (K092609)  SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K111540)  SYNTHES CORTICAL SCREWS (K112583)  SYNTHES LCP DISTAL FEMUR PLATES (K062564)  SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114)  SYNTHES VA…
Synthes (USA) Products, LLC2011—
*K062564Synthes LCP Distal Femur Plates
Summary page 6
…N PLATES (LCP) (K092609)  SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K111540)  SYNTHES CORTICAL SCREWS (K112583)  SYNTHES LCP DISTAL FEMUR PLATES (K062564)  SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114)  SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070)  SY…
Synthes (Usa)2006—
*K012114Synthes Locking Distal Radius Plating System
Summary page 6
…CLE PLATE SYSTEM (K111540)  SYNTHES CORTICAL SCREWS (K112583)  SYNTHES LCP DISTAL FEMUR PLATES (K062564)  SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114)  SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070)  SYNTHS ONE-THIRD TUBULAR DCL PLATE (K011335) 7. Device Descri…
Synthes (Usa)20013
*K120070Synthes Variable Angle LCP Elbow System
Summary page 6
…(K112583)  SYNTHES LCP DISTAL FEMUR PLATES (K062564)  SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114)  SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070)  SYNTHS ONE-THIRD TUBULAR DCL PLATE (K011335) 7. Device Description This product is intended for closure /or bone…
Synthes USA20121
*K011335Synths One-Third Tubular DCL Plate
Summary page 6
…062564)  SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114)  SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070)  SYNTHS ONE-THIRD TUBULAR DCL PLATE (K011335) 7. Device Description This product is intended for closure /or bone fixation of fractures, fusion, osteotomies, non-unio…
Synthes (Usa)20012

Also cleared against K230546: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 29 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
  • 30 of the 176 ancestors have a recall of any class.
  • 1 other device also cites its predicate K230546.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and…

Read the full statement (250 words)

The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Foot System is indicated for fixation of foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Universal Plates are indicated for fixation of arm (humerus, radius, ulna), leg (femur, tibia, fibula), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K230546

1 other device cites the same predicate.

  • K254182AsterOsteonic Co., Ltd. · 2026

More from Osteonic Co., Ltd.

20 FDA decisions under this applicant name. See the company

  • K254182AsterOsteonic Co., Ltd. · 2026
  • K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd. · 2024
  • K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. · 2024
  • K230546SignexOsteonic Co., Ltd. · 2024
  • K233659Suture WingOsteonic Co., Ltd. · 2023

Recent decisions in HRS

The HRS category page

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  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K243469 · printed Nov 5, 2026

Cite this page

510(k) Report. “K243469: Signex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243469

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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