510(k) · Cleared
ClearedHEMC 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
Hospital Equipment Manufacturing Company · HRS Plate, Fixation, Bone
Cleared on Oct 27, 2022 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 13 other predicates after a 90-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Oct 27, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 11 generations to K962616 (1996). 99 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 deviceK222282 HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Hospital Equipment Manufacturing Company · 2022
- Descendant · cites it directly · 0 of its ownK230507 Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal · 2024
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 deviceK222282 HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Hospital Equipment Manufacturing Company · 2022
Most influential descendants
Showing 1 of 1 · See all- K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal · 2024 · 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) | K222282 | HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System | Hospital Equipment Manufacturing Company | 2022 | — |
| +1 | K230507 | Zimed Distal Medial Tibial Plate and Screw System | Zimed Medikal | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 9 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (14)
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 6…with which we are declaring substantial equivalence: No. Primary Predicate Device 1 Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) No. Other Predicate Devices 2 Synthes 3.5mm LCP Clavicle Plate System (K111540) 3 Synthes V… | 2008 |
| * | K111540 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 6…1 Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) No. Other Predicate Devices 2 Synthes 3.5mm LCP Clavicle Plate System (K111540) 3 Synthes Variable Angle LCP Elbow System (K120070) 4 Synthes Variable Angle Locking Compression Pla… | 2011 |
| * | K120070 | Synthes Variable Angle LCP Elbow SystemSummary page 6…(K082807) No. Other Predicate Devices 2 Synthes 3.5mm LCP Clavicle Plate System (K111540) 3 Synthes Variable Angle LCP Elbow System (K120070) 4 Synthes Variable Angle Locking Compression Plates Distal Radius System (K071184) 5 Synthes 3.5mm L… | 2012 |
| * | K071184 | Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius SystemSummary page 6…ystem (K111540) 3 Synthes Variable Angle LCP Elbow System (K120070) 4 Synthes Variable Angle Locking Compression Plates Distal Radius System (K071184) 5 Synthes 3.5mm LCP Distal Humerus System (K033995) 6 Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal… | 2007 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 6…ystem (K120070) 4 Synthes Variable Angle Locking Compression Plates Distal Radius System (K071184) 5 Synthes 3.5mm LCP Distal Humerus System (K033995) 6 Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plate (K032269) 7 Synthes (USA) LCP® Proximal… | 2004 |
| * | K032269 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 6…tal Radius System (K071184) 5 Synthes 3.5mm LCP Distal Humerus System (K033995) 6 Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plate (K032269) 7 Synthes (USA) LCP® Proximal Humerus Plates, Long (K041860) 8 Synthes LCP Distal Femur Plates (K062… | 2003 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 6…s System (K033995) 6 Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plate (K032269) 7 Synthes (USA) LCP® Proximal Humerus Plates, Long (K041860) 8 Synthes LCP Distal Femur Plates (K062564) 9 Synthes (USA) Medial Distal Tibia Plate (K001945)… | 2004 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 6…mm LCP® Medial Proximal Tibia Plate (K032269) 7 Synthes (USA) LCP® Proximal Humerus Plates, Long (K041860) 8 Synthes LCP Distal Femur Plates (K062564) 9 Synthes (USA) Medial Distal Tibia Plate (K001945) 10 Synthes LCP Proximal Tibia Plate (K011978)… | 2006 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 6…hes (USA) LCP® Proximal Humerus Plates, Long (K041860) 8 Synthes LCP Distal Femur Plates (K062564) 9 Synthes (USA) Medial Distal Tibia Plate (K001945) 10 Synthes LCP Proximal Tibia Plate (K011978) 11 Synthes Cortical Screws (K112583) 12 Syn… | 2000 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 6…8 Synthes LCP Distal Femur Plates (K062564) 9 Synthes (USA) Medial Distal Tibia Plate (K001945) 10 Synthes LCP Proximal Tibia Plate (K011978) 11 Synthes Cortical Screws (K112583) 12 Synthes (USA) 6.5 mm Cancellous Screws (K061621) 13… | 2001 |
| * | K112583 | Synthes Cortical ScrewsSummary page 6…64) 9 Synthes (USA) Medial Distal Tibia Plate (K001945) 10 Synthes LCP Proximal Tibia Plate (K011978) 11 Synthes Cortical Screws (K112583) 12 Synthes (USA) 6.5 mm Cancellous Screws (K061621) 13 Synthes 6.5mm Cannulated Screws (K021932)… | 2011 |
| * | K061621 | Synthes (Usa) 6.5 MM Cancellous ScrewsSummary page 6…945) 10 Synthes LCP Proximal Tibia Plate (K011978) 11 Synthes Cortical Screws (K112583) 12 Synthes (USA) 6.5 mm Cancellous Screws (K061621) 13 Synthes 6.5mm Cannulated Screws (K021932) 14 Synthes 7.0/7.3 cannulated cancellous screws (K962011)… | 2006 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 6…1978) 11 Synthes Cortical Screws (K112583) 12 Synthes (USA) 6.5 mm Cancellous Screws (K061621) 13 Synthes 6.5mm Cannulated Screws (K021932) 14 Synthes 7.0/7.3 cannulated cancellous screws (K962011) a(4). A description of the device that is the subject of… | 2002 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 6…Synthes (USA) 6.5 mm Cancellous Screws (K061621) 13 Synthes 6.5mm Cannulated Screws (K021932) 14 Synthes 7.0/7.3 cannulated cancellous screws (K962011) a(4). A description of the device that is the subject of the premarket notification submission, such as might be found in the l… | 1996 |
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 |
|---|---|---|---|
| K230507 | Zimed Distal Medial Tibial Plate and Screw System | 2024 | 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 26 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 22 of the 99 ancestors have a recall of any class.
- Of its descendants, K230507 (Zimed Medikal, 2024) has gone furthest, with 0 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. 2022, 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?
The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius. The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for…
Read the full statement (685 words)
The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.
The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.
The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavicle Plate With Lateral Extension is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and non-unions of the olecranon.
The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.
The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.
The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended 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 nonunions and malunions of the medial proximal tibia and tibia shaft.
The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also, for use in fixation of non-unions and malunions.
The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, malunions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Ø2.7 mm Secure Locking Screws, Self Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.
The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, Full Thread, Ø4.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.
The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, and 7.0mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, are indicated for fracture fixation of large bones and large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222282: HEMC 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 4, 2026. https://510kreport.com/device/K222282
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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