510(k) · Cleared
ClearedInternal Locking Plate and Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Dec 15, 2023 as substantially equivalent to K063049 (Synthes (Usa), 2006) and 9 other predicates after a 128-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Dec 15, 2023
- Review
- 128 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K981372 (1998). 29 ancestors in all, the oldest K882831 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- This deviceK232394 Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| 0 (this device) | K232394 | Internal Locking Plate and Screw Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 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? (10)
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 |
|---|---|---|---|
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 5…Synthes (USA) Modular Mini Fragment LCP Trade name System; 510(K) number K063049 Regulatory Class II Regulation Number 21 CFR 888.3030, 21 CFR 888.3040 Primary Predi… | 2006 |
| * | K073186 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 6…product codes HWC: Screw, Fixation, Bone Manufacturer DePuy Synthes K073186, Synthes 3.5mm LCP Clavicle Plate System;… | 2007 |
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 6…K073186, Synthes 3.5mm LCP Clavicle Plate System; K011815, Synthes LCP Proximal Humerus Plate; K033995, 3.5mm LCP Distal Humerus System;… | 2001 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 6…System; K011815, Synthes LCP Proximal Humerus Plate; K033995, 3.5mm LCP Distal Humerus System; K083694, Synthes 2.4mm VA-LCP… | 2004 |
| * | K083694 | Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius PlatesSummary page 6…Synthes LCP Proximal Humerus Plate; K033995, 3.5mm LCP Distal Humerus System; K083694, Synthes 2.4mm VA-LCP Two-Column Volar Distal Radius Plate;… | 2009 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 6…K083694, Synthes 2.4mm VA-LCP Two-Column Volar Distal Radius Plate; K062564, Synthes LCP Distal Femur Plate; Trade name /510(K) K032269, Synthes (USA) 3.5/4.5mm LCP… | 2006 |
| * | K032269 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 6…wo-Column Volar Distal Radius Plate; K062564, Synthes LCP Distal Femur Plate; Trade name /510(K) K032269, Synthes (USA) 3.5/4.5mm LCP number Medial Proximal Tibia Plates;… | 2003 |
| * | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSummary page 6…510(K) K032269, Synthes (USA) 3.5/4.5mm LCP number Medial Proximal Tibia Plates; K092812, Synthes (USA) 2.7mm /3.5mm LCP Anterolateral Distal Tibia Plates; Additional Predi… | 2010 |
| * | K083213 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 6…USA) 2.7mm /3.5mm LCP Anterolateral Distal Tibia Plates; Additional Predicate K083213, Synthes 2.7mm/3.5mm LCP Distal Devices Fibula Plates-Modification;… | 2008 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 6…K083213, Synthes 2.7mm/3.5mm LCP Distal Devices Fibula Plates-Modification; K082807, Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with… | 2008 |
| † | K222031 | Spinal Inner Fixation System | 2022 |
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 25 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 7 of the 29 ancestors have a recall of any class.
- 39 other devices also cite its predicate K063049.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or stabilization of bones in various anatomical regions. 3.5mm LCP Clavicle Plate 3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. 3.5mm LCP Proximal Humeral Plate LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal…
Read the full statement (374 words)
Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or stabilization of bones in various anatomical regions.
3.5mm LCP Clavicle Plate
3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.
3.5mm LCP Proximal Humeral Plate
LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
3.5mm LCP Distal Humerus plate
3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
2.4mm LCP Volar Distal Radius Plate
2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
5.0mm LCP Distal Femur Plate
5.0 LCP Distal Femur Plate is indicated for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.
3.5mm LCP Medial Proximal Tibial Plate
3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.
3.5mm LCP Anterolateral Distal Tibia Plate
3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
2.7mm/3.5mm LCP Distal Fibula Plate
2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
2.0mm LCP Condylar Plate
2.0mm LCP condylar Plate is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
3.5mm Round Hole Reconstruction Locking Plate
The 3.5mm Round Hole Reconstruction Locking Plates is indicated for fixation of fractures, osteotomies and non-unions of the pelvis, particularly in osteopenic bone for adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232394: Internal Locking Plate and Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232394
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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