510(k) · Cleared
ClearedGPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gpc Medical, Ltd. · HRS Plate, Fixation, Bone
Cleared on May 17, 2016 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 21 other predicates after a 145-day review. Its family tree reaches back 5 generations to 1996. 15 later devices descend from it.
- Decided
- May 17, 2016
- Review
- 145 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 22
Its longest line of descent runs back 5 generations to K962616 (1996). 53 ancestors in all, the oldest K882831 (1988). 15 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 4 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 3 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 2 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 1 generation backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- This deviceK153716 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Gpc Medical, Ltd. · 2016
- Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
- K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −4 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −3 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −2 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −1 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| 0 (this device) | K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | Gpc Medical, Ltd. | 2016 | — |
| +1 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| +3 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 | Decided |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 7…4.5mm Narrow Locking Plate Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) 02 4.5mm Broad Locking Plate Synthes 3.5 and 4.5mm Locking… | 2008 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 7…lates (K082807) 04 4.5mm Reconstruction Locking Plate Synthes 4.5 mm LCP Straight Reconstruction Plate (K051986) 05 Proximal Femur Locking Plate Synthes (USA) LCP Proximal Femur… | 2005 |
| * | K030858 | Synthes (Usa) LCP Proximal Femur Plate and ScrewsSummary page 7…(K051986) 05 Proximal Femur Locking Plate Synthes (USA) LCP Proximal Femur Plate (K030858) 06 Locking Lateral Proximal Tibia Plate, Left and Right Synthes LCP Proximal… | 2003 |
| * | K023802 | Synthes 4.5 MM Titanium LCP Proximal Tibia Plating SystemSummary page 7…Proximal Tibia Plate, Left and Right Synthes LCP Proximal Tibia Plate (K023802, K030597, K983787) 07 4.5mm Distal Femur Locking Plate, Left and Synthes LCP Distal Femur Right… | 2003 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 7…Tibia Plate, Left and Right Synthes LCP Proximal Tibia Plate (K023802, K030597, K983787) 07 4.5mm Distal Femur Locking Plate, Left and Synthes LCP Distal Femur Right… | 2003 |
| * | K983787 | Synthes Proximal Tibia Plating SystemSummary page 7…ate, Left and Right Synthes LCP Proximal Tibia Plate (K023802, K030597, K983787) 07 4.5mm Distal Femur Locking Plate, Left and Synthes LCP Distal Femur Right… | 1999 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 7…(K023802, K030597, K983787) 07 4.5mm Distal Femur Locking Plate, Left and Synthes LCP Distal Femur Right Plates (K062564) 08 Locking T-Plate 3.5mm, Oblique Angled, Left Synthes Small Fragment Dynamic and Right… | 2006 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 7…thes Small Fragment Dynamic and Right Compression Locking( DCL) System (K000684) 09 Small Dynamic Compression Plate 3.5mm with Synthes 3.5 (USA) Locking LC Under Cuts… | 2000 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 7…l Tibia Plate (K030597) OR Synthes LCP Proximal Tibia Plates (K011978) Rev: 02 Date: 27.04.2016 SECTION 5… | 2001 |
| * | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSummary page 8…L LTD 13 Locking Anterolateral Tibia Distal Plate 3.5mmSynthes (USA) LCP Anterolateral Distal Tibia Plate 3.5 (K092812) 14 Locking Clavicle Hook Plate 3.5mm, Left and Synthes Clavicle Hook Plate Right… | 2010 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 8…Distal Tibia Plate 3.5 (K092812) 14 Locking Clavicle Hook Plate 3.5mm, Left and Synthes Clavicle Hook Plate Right (K061753) 15 3.5mm Proximal Humerus Locking Plate Proximal humerus plate long… | 2006 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 8…(K061753) 15 3.5mm Proximal Humerus Locking Plate Proximal humerus plate long Synthes K041860 K062494 EBI Optilock Upper… | 2004 |
| * | K062494 | Ebi Optilock Upper Extremity Plating SystemSummary page 8…e Proximal humerus plate long Synthes K041860 K062494 EBI Optilock Upper Extremity Plating System 16 Distal Humerus Lockin… | 2006 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 8…emity Plating System 16 Distal Humerus Locking Plate, Size 2.7/3.5mm, Synthes 3.5mm LCP Distal Left and Right Humerus System (K033995) 17 Distal Humerus Locking Plate, 2.7/3.5mm with Synthes 3.5mm LCP Distal Lateral Support, Left and Right… | 2004 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 8…Humerus System (K033995) 18 Locking Medial Distal Tibia Plate without Tab, Synthes Medial Distal Tibia Plate Left and Right (K001945) 19 Locking Philous Plate Synthes (USA) LCP® Proximal… | 2000 |
| * | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS)Summary page 8…ynthes (USA) LCP® Proximal Humerus Plates, Long (K041860) 20 ‘T’ Distal Radius 2.4mm Locking Plate K982732 or K012114 (Synthes locking distal radius plating system) 21 Lockin… | 1998 |
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 8…) LCP® Proximal Humerus Plates, Long (K041860) 20 ‘T’ Distal Radius 2.4mm Locking Plate K982732 or K012114 (Synthes locking distal radius plating system) 21 Locking Distal Ra… | 2001 |
| * | K040777 | LCP Radial Head Plating SystemSummary page 8…ng system) 21 Locking Distal Radius Buttress Plate 2.4mm Synthes (USA) LCP Radial Head Plating System (K040777) 22 Self Tapping Locking Screw 2.4mm Synthes 2.4mm Titanium locking… | 2004 |
| * | K033975 | Synthes 2.4 MM Titanium (TI.) Locking ScrewsSummary page 8…System (K040777) 22 Self Tapping Locking Screw 2.4mm Synthes 2.4mm Titanium locking screw (K033975) K051567 APTUS Titanium Fixation… | 2004 |
| * | K051567 | Aptus Titanium Osteosynthesis SystemSummary page 8…Synthes 2.4mm Titanium locking screw (K033975) K051567 APTUS Titanium Fixation System 23 Self Tapping Locking Screw 2.7mm… | 2005 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 9…gment Dynamic Compression Locking (DCL) System (K000682) K051567 APTUS Titanium Fixation… | 2000 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 9…System 26 6.5mm Self Tapping Locking Cannulated Synthes Cannulated Screw System Screw K021932 K051567 APTUS Titanium Fixation… | 2002 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163361 | ANTHEM™ Fracture System | 2017 | 14 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 11 of the 53 ancestors have a recall of any class.
- Of its descendants, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 descendants of its own.
- 42 other devices also cite its predicate K082807.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile.
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for
treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna,
radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
The system is indicated for use in adult patients only. All implants are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153716
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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