510(k) · Cleared

Cleared

Genostis Osteosynthesis System

K242988510(k) TraditionalCleared Jun 27, 2025274-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

Genostis AF · HRS Plate, Fixation, Bone

Cleared on Jun 27, 2025 as substantially equivalent to K001945 (Synthes (Usa), 2000) and 21 other predicates after a 274-day review. Its family tree reaches back 12 generations to 1996.

Decided: Jun 27, 2025
Review: 274 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 22

Its longest line of descent runs back 12 generations to K962616 (1996). 115 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

By dateBy generation

Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
8 generations between
3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
This deviceK242988 Genostis Osteosynthesis SystemGenostis AF · 2025

Show all 12 generations

Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
This deviceK242988 Genostis Osteosynthesis SystemGenostis AF · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−12	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−11	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−10	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−9	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−8	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−7	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
−6	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
−5	K071563	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2007	—
−4	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories	Smith & Nephew, Inc.	2009	—
−3	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—
−2	K112583	Synthes Cortical Screws	Synthes (USA) Products, LLC	2011	—
−1	K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated…	Synthes USA Products, LLC	2017	—
0 (this device)	K242988	Genostis Osteosynthesis System	Genostis AF	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1988	1	0
1989	1	0
1990	1	0
1991	2	0
1992	1	0
1993	2	0
1994	4	0
1995	2	0
1996	9	0
1997	1	0
1998	4	0
1999	4	0
2000	10	0
2001	11	0
2002	6	0
2003	6	0
2004	6	0
2005	6	0
2006	8	0
2007	5	0
2008	5	0
2009	3	0
2010	2	0
2011	2	0

FIG. 1 — Lineage of K242988, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K001945	Synthes (Usa) Medial Distal Tibia Plates Summary page 7 …and Plate, Fixation, Bone 888.3030 HRS, HWC Predicate Devices 21 CFR 807.92(3)(3L Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K001945 Synthes LCP Low Bend Medial Distal Tibia Plates 3.5mm HRS K000682 Synthes 4.5 mm Narrow LCP Plates and 5.00 mm Locking Screy\| \| H…	Synthes (Usa)	2000	—
*	K000682	Synthes Large Fragment Dynamic Compression Locking (DCL) System Summary page 7 …21 CFR 807.92(3)(3L Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K001945 Synthes LCP Low Bend Medial Distal Tibia Plates 3.5mm HRS K000682 Synthes 4.5 mm Narrow LCP Plates and 5.00 mm Locking Screy\| \| HRS K000684 Synthes LCP Olecranon Plate and Sysnthes 3.5 mm Locking…	Synthes (Usa)	2000	—
*	K000684	Small Fragment Dynamic Compression Locking (DCL) System Summary page 7 …is listed first) Product Code K001945 Synthes LCP Low Bend Medial Distal Tibia Plates 3.5mm HRS K000682 Synthes 4.5 mm Narrow LCP Plates and 5.00 mm Locking Screy\| \| HRS K000684 Synthes LCP Olecranon Plate and Sysnthes 3.5 mm Locking Sgg\| \| HRS K010321 Synthes Quarter Tubular Plate 2.7 with Collar HRS K010…	Synthes (Usa)	2000	1
*	K010321	Modular Foot System - 2.7 MM Module Summary page 7 …bia Plates 3.5mm HRS K000682 Synthes 4.5 mm Narrow LCP Plates and 5.00 mm Locking Screy\| \| HRS K000684 Synthes LCP Olecranon Plate and Sysnthes 3.5 mm Locking Sgg\| \| HRS K010321 Synthes Quarter Tubular Plate 2.7 with Collar HRS K010 766 LCP L-Buttress Plates 4.5/5.0 HRS K011335 Synthes 3.5 mm LCP one-third…	Synthes (Usa)	2001	—
*	K010766	Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate Summary page 7 …tes and 5.00 mm Locking Screy\| \| HRS K000684 Synthes LCP Olecranon Plate and Sysnthes 3.5 mm Locking Sgg\| \| HRS K010321 Synthes Quarter Tubular Plate 2.7 with Collar HRS K010 766 LCP L-Buttress Plates 4.5/5.0 HRS K011335 Synthes 3.5 mm LCP one-third tubular plate HRS Page 265 K030597 Synthe…	Synthes (Usa)	2001	—
*	K011335	Synths One-Third Tubular DCL Plate Summary page 7 …4 Synthes LCP Olecranon Plate and Sysnthes 3.5 mm Locking Sgg\| \| HRS K010321 Synthes Quarter Tubular Plate 2.7 with Collar HRS K010 766 LCP L-Buttress Plates 4.5/5.0 HRS K011335 Synthes 3.5 mm LCP one-third tubular plate HRS Page 265 K030597 Synthes LCP Proximal Tibial Plate 3.5, Lateral H…	Synthes (Usa)	2001	2
*	K030597	Synthes 3.5MM Titanium LCP Proximal Tibia Plates Summary page 8 …hes Quarter Tubular Plate 2.7 with Collar HRS K010 766 LCP L-Buttress Plates 4.5/5.0 HRS K011335 Synthes 3.5 mm LCP one-third tubular plate HRS Page 265 K030597 Synthes LCP Proximal Tibial Plate 3.5, Lateral HRS K033995 Synthes LCP Distal Humerus Plate , dorsolateral with support HRS K0407…	Synthes (Usa)	2003	—
*	K033995	3.5 MM LCP Distal Humerus System Summary page 8 …L-Buttress Plates 4.5/5.0 HRS K011335 Synthes 3.5 mm LCP one-third tubular plate HRS Page 265 K030597 Synthes LCP Proximal Tibial Plate 3.5, Lateral HRS K033995 Synthes LCP Distal Humerus Plate , dorsolateral with support HRS K040777 Synthes LCP Proximal Radius Plates 2.4 HRS K041911 Synth…	Synthes (Usa)	2004	1
*	K040777	LCP Radial Head Plating System Summary page 8 …r plate HRS Page 265 K030597 Synthes LCP Proximal Tibial Plate 3.5, Lateral HRS K033995 Synthes LCP Distal Humerus Plate , dorsolateral with support HRS K040777 Synthes LCP Proximal Radius Plates 2.4 HRS K041911 Synthes 4.5 mm Curved Broad LCP Plates HRS K052390 Synthes LCP Proximal Latera…	Synthes (Usa)	2004	—
*	K041911	Synthes (Usa) LCP Curved Plates Summary page 8 …es LCP Proximal Tibial Plate 3.5, Lateral HRS K033995 Synthes LCP Distal Humerus Plate , dorsolateral with support HRS K040777 Synthes LCP Proximal Radius Plates 2.4 HRS K041911 Synthes 4.5 mm Curved Broad LCP Plates HRS K052390 Synthes LCP Proximal Lateral Tibia Plate 4.5/5.0 HRS K061753 Synthes LCP Clavi…	Synthes (Usa)	2004	1
*	K052390	Synthes LCP Proximal Tibia Plates Line Extension Summary page 8 …95 Synthes LCP Distal Humerus Plate , dorsolateral with support HRS K040777 Synthes LCP Proximal Radius Plates 2.4 HRS K041911 Synthes 4.5 mm Curved Broad LCP Plates HRS K052390 Synthes LCP Proximal Lateral Tibia Plate 4.5/5.0 HRS K061753 Synthes LCP Clavicle Hook Plate HRS K062564 Synthes LCP Distal Femur…	Synthes (Usa)	2005	—
*	K061753	Synthes (Usa) Clavicle Hook Plates Summary page 8 …rt HRS K040777 Synthes LCP Proximal Radius Plates 2.4 HRS K041911 Synthes 4.5 mm Curved Broad LCP Plates HRS K052390 Synthes LCP Proximal Lateral Tibia Plate 4.5/5.0 HRS K061753 Synthes LCP Clavicle Hook Plate HRS K062564 Synthes LCP Distal Femur Plates HRS K063049 Synthes LCP plate 2.7 straight Synthes 2.…	Synthes (Usa)	2006	—
*	K062564	Synthes LCP Distal Femur Plates Summary page 8 …lates 2.4 HRS K041911 Synthes 4.5 mm Curved Broad LCP Plates HRS K052390 Synthes LCP Proximal Lateral Tibia Plate 4.5/5.0 HRS K061753 Synthes LCP Clavicle Hook Plate HRS K062564 Synthes LCP Distal Femur Plates HRS K063049 Synthes LCP plate 2.7 straight Synthes 2.4/2.7 mm locking scrgy\| \| HRS K073186 Synthe…	Synthes (Usa)	2006	—
*	K063049	Synthes (Usa) Modular Mini Fragment LCP System Summary page 8 …Broad LCP Plates HRS K052390 Synthes LCP Proximal Lateral Tibia Plate 4.5/5.0 HRS K061753 Synthes LCP Clavicle Hook Plate HRS K062564 Synthes LCP Distal Femur Plates HRS K063049 Synthes LCP plate 2.7 straight Synthes 2.4/2.7 mm locking scrgy\| \| HRS K073186 Synthes LCP Superior Clavicle Plate HRS K080522 Sy…	Synthes (Usa)	2006	4
*	K073186	Synthes 3.5MM LCP Clavicle Plate System Summary page 8 …RS K061753 Synthes LCP Clavicle Hook Plate HRS K062564 Synthes LCP Distal Femur Plates HRS K063049 Synthes LCP plate 2.7 straight Synthes 2.4/2.7 mm locking scrgy\| \| HRS K073186 Synthes LCP Superior Clavicle Plate HRS K080522 Synthes 3.5 mm T Plate HRS K082625 Synthes PHILOS long-proximal diaphyseal humera…	Synthes (Usa)	2007	—
*	K080522	Synthes 3.5 MM LCP Distal Tibia T Plates Summary page 8 …062564 Synthes LCP Distal Femur Plates HRS K063049 Synthes LCP plate 2.7 straight Synthes 2.4/2.7 mm locking scrgy\| \| HRS K073186 Synthes LCP Superior Clavicle Plate HRS K080522 Synthes 3.5 mm T Plate HRS K082625 Synthes PHILOS long-proximal diaphyseal humeral plate 3.5 HRS K092812 Synthes LCP Anterolatera…	Synthes (Usa)	2008	—
*	K082625	Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates Summary page 8 …tes HRS K063049 Synthes LCP plate 2.7 straight Synthes 2.4/2.7 mm locking scrgy\| \| HRS K073186 Synthes LCP Superior Clavicle Plate HRS K080522 Synthes 3.5 mm T Plate HRS K082625 Synthes PHILOS long-proximal diaphyseal humeral plate 3.5 HRS K092812 Synthes LCP Anterolateral Distal Tibia Plate 3.5 HRS K10299…	Synthes (Usa)	2008	1
*	K092812	Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates Summary page 8 …ing scrgy\| \| HRS K073186 Synthes LCP Superior Clavicle Plate HRS K080522 Synthes 3.5 mm T Plate HRS K082625 Synthes PHILOS long-proximal diaphyseal humeral plate 3.5 HRS K092812 Synthes LCP Anterolateral Distal Tibia Plate 3.5 HRS K102998 Acumed Acu-Loc Plating System HRS K112583 Synthes 2.7/3.5 mm Cortex…	Synthes (Usa)	2010	—
*	K102998	Congruent Bone Plate System Summary page 8 …HRS K080522 Synthes 3.5 mm T Plate HRS K082625 Synthes PHILOS long-proximal diaphyseal humeral plate 3.5 HRS K092812 Synthes LCP Anterolateral Distal Tibia Plate 3.5 HRS K102998 Acumed Acu-Loc Plating System HRS K112583 Synthes 2.7/3.5 mm Cortex Screw HWC K161616 Synthes 4.5 mm Cortex Screw HWC KO71715 Acu…	Acumed, LLC	2011	—
*	K112583	Synthes Cortical Screws Summary page 8 …2625 Synthes PHILOS long-proximal diaphyseal humeral plate 3.5 HRS K092812 Synthes LCP Anterolateral Distal Tibia Plate 3.5 HRS K102998 Acumed Acu-Loc Plating System HRS K112583 Synthes 2.7/3.5 mm Cortex Screw HWC K161616 Synthes 4.5 mm Cortex Screw HWC KO71715 Acumed Acu_LOC 2 Plating System HRS Device De…	Synthes (USA) Products, LLC	2011	—
*	K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… Summary page 8 …humeral plate 3.5 HRS K092812 Synthes LCP Anterolateral Distal Tibia Plate 3.5 HRS K102998 Acumed Acu-Loc Plating System HRS K112583 Synthes 2.7/3.5 mm Cortex Screw HWC K161616 Synthes 4.5 mm Cortex Screw HWC KO71715 Acumed Acu_LOC 2 Plating System HRS Device Description Summary 21 CFR 807.92(a)(4) The G…	Synthes USA Products, LLC	2017	—
*	K071715	Acumed Congruent Bone Plate System	Acumed, LLC	2007	—

Also cleared against K001945: 16 other devices →

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 7 companies; a new generation was cleared every 1.8 years on median.
22 of the 115 ancestors have a recall of any class.
16 other devices also cite its predicate K001945.

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

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

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

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

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?

Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions. One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression. Straight Plates 2.4/2.7 are indicated for fixation of…

Read the full statement (729 words)

Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.

One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required.

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

— Fractures of the clavicle shaft

— Fractures of the lateral clavicle

— Malunions of the clavicle

— Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

— Split-type fractures of the lateral tibial plateau

— Lateral split fractures with associated depressions

— Pure central depression fractures

— Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

— Intraarticular fractures of the distal humerus

— Supracondylar fractures of the distal humerus

— Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

— Intraarticular fractures of the distal humerus

— Supracondylar fractures of the distal humerus

— Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

— Complex extra- and intra-articular olecranon fractures

— Non-unions of the proximal ulna

— Osteotomies

— Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia.

The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia.

The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

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

https://510kreport.com/device/K242988 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242988: Genostis Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242988

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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