510(k) · Cleared
ClearedCARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocare · HRS Plate, Fixation, Bone
Cleared on Jun 17, 2016 as substantially equivalent to K923613 (Synthes (Usa), 1993) and 19 other predicates after a 207-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Jun 17, 2016
- Review
- 207 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 20
Its longest line of descent runs back 11 generations to K962616 (1996). 101 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK153374 CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Orthocare · 2016
- Descendant · cites it directly · 0 of its ownK192619 Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2020
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK153374 CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Orthocare · 2016
Most influential descendants
Showing 1 of 1 · See all- K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −1 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| 0 (this device) | K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE… | Orthocare | 2016 | — |
| +1 | K192619 | Pitkar Locked Plating System | S.H.Pitkar Orthotools Pvt., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (20)
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 |
|---|---|---|---|
| * | K923613 | Synthes Limited Contact-Dynamic Hip Screw ImplantSummary page 7…Hip Screw Plate (with Dynamic Compression Synthes Limited Contact-Dynamic Hip Screw Holes) (Long Barrel) Implant (LC-DHS)” for K923613 Dynamic Hip Screw Plate (with Dynamic Compression Synthes Titanium Limited Contact-Dynamic Holes) (Sho… | 1993 |
| * | K953607 | Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Summary page 7…late (with Dynamic Compression Synthes Titanium Limited Contact-Dynamic Holes) (Short Barrel) Hip Screw Implant (Ti LC-DHS)” for K953607 2. Dynamic Condylar Plate with Dynamic Compression Synthes dynamic condylar screw or d.c.s.… | 1996 |
| * | K840954 | Dynamic Condylar Screw or D.C.S.Summary page 7…c Condylar Plate with Dynamic Compression Synthes dynamic condylar screw or d.c.s. Holes (Barrel length 25 mm) K840954 3. Dynamic Hip Screw, Ø 12.5mm with Compression Synthes Limited Contact-Dynamic Hip Screw… | 1984 |
| * | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Summary page 7…Compression Plates (LCP) (K092609) 5. Narrow Locking Plate For 4.5mm/5.0mm Screws… | 2009 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 7…Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) 6. Locking Reconstruction Plate 4.5mm Synthes 4.5 mm LCP Straight… | 2008 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 7…ruction Plate 4.5mm Synthes 4.5 mm LCP Straight Reconstruction Plate (K051986) 7. Synthes 3.5 mm and 4.5 mm LCP Curved Bro… | 2005 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 7…Locking distal femur plate – right Synthes LCP Distal Femur Locking distal femur plate - left Plates (K062564) 10. K030597 Synthes 3.5 Titanium LCP Proximal… | 2006 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 7…emur Locking distal femur plate - left Plates (K062564) 10. K030597 Synthes 3.5 Titanium LCP Proximal Lateral Tibia Locking Plate Left Proximal Tibia Plate (For Tita… | 2003 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 7…Proximal Lateral Tibia Locking Plate Right Synthes LCP Proximal Tibia Plate (K011978) (For Stainless Steel) ^ d/KEϬϱ… | 2001 |
| * | K030858 | Synthes (Usa) LCP Proximal Femur Plate and ScrewsSummary page 8…Proximal Lateral Plates L/R 5 Holes Synthes (USA) LCP Proximal Femur Plate To 13 Holes, Left and Screws (K030858) Locking Femoral Proximal Lateral Plates L/R 5 Holes To 13 Holes, Right 12. Locking Humer… | 2003 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 8…g Humeral Distal Dorsal Plates L/R Without Synthes 3.5mm LCP Distal Support 2.7/3.5, Left & Right Humerus System (K033995) 13. Locking Humeral Distal Dorsal Plates L/R With Lateral Synthes 3.5mm LCP Distal Support 2.7/3.5,… | 2004 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 8…Distal Tibial Locking Plate 2.7/3.5, Left Synthes Medial Distal Tibia Plate (K001945) 15 Distal Tibial Locking Plate 2.7/3.5, Right Synthes Medial Distal Tibia Plate… | 2000 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 8…proximal humeral plate - Long Synthes (USA) LCP® Proximal Humerus Locking philos proximal humeral plate - Short Plates, Long (K041860) 17. Small Locking Plate For Dia 3.5mm Screws Synthes 3.5 and 4.5mm Locking… | 2004 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 8…Locking T-Plate Oblique angled For Dia 3.5mm Compression Locking( DCL) System Screws, Left (K000684) 20 Synthes Small Fragment Dynamic Locking T-… | 2000 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 9…Compression Locking (DCL) System (K000682) 34. Cortex Screw Ø 3.5mm, Self Tapping Synthes Cortical Screws K112583 35. Cortex S… | 2000 |
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 9…icle Hook Plate (K061753) 27. Locking Distal Dorsal Radius T-Plates 2.7mm, 3Holes K012114 (Synthes locking distal radius plating system) 28… | 2001 |
| * | K040777 | LCP Radial Head Plating SystemSummary page 9…em) 28 Locking Distal Dorsal Radius T-Plates 2.7mm, 4Holes LCP Radial Head Plating System (K040777) 29. Locking Compression EXTRA-ARTICULAR VOLAR DISTAL RADIUS PLATES 2.4 HEAD 4HOLES, Left… | 2004 |
| * | K050110 | Synthes (Usa) LCP Modular Foot PlatesSummary page 9…Synthes LCP Modular Foot plate 31. Locking Head Screw, Dia - 2.7mm - Self Tapping (K050110) 32. Locking Head Screw, Dia - 3.5mm - Self Tapping Synthes Small Fragment Dynamic… | 2005 |
| * | K112583 | Synthes Cortical ScrewsSummary page 9…(K000682) 34. Cortex Screw Ø 3.5mm, Self Tapping Synthes Cortical Screws K112583 35. Cortex Screw Ø 4.5mm, Self Tapping Synthes Cortical Screws (K112583) a4). A descripti… | 2011 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 9…LCP Clavicle Hook Plate, Left Synthes Clavicle Hook Plate (K061753) 26 LCP Clavicle Hook Plate, Right Synthes Clavicle Hook Plate… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192619 | Pitkar Locked Plating System | 2020 | 0 |
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 6 companies; a new generation was cleared every 1.6 years on median.
- 21 of the 101 ancestors have a recall of any class.
- Of its descendants, K192619 (S.H.Pitkar Orthotools Pvt., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K923613.
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?
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are provided non-sterile. CARE 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). CARE Brand of DHS/DCS Plating System is…
Read the full statement (102 words)
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are provided non-sterile.
CARE 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).
CARE Brand of DHS/DCS Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures.
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/K153374 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153374: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153374
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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