510(k) · Cleared
ClearedTyber Medical Anatomical Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · HRS Plate, Fixation, Bone
Cleared on May 31, 2024 as substantially equivalent to K153575 (Tyber Medical, LLC, 2016) and 1 other predicate after a 30-day review. Its family tree reaches back 19 generations to 1996. 2 later devices descend from it.
- Decided
- May 31, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K962616 (1996). 415 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 15 generations between
- 3 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 2 generations backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- 1 generation backK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- This deviceK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- Descendant · cites it directly · 1 of its ownK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
Show all 19 generations
- Root · 19 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 18 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 17 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 16 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 15 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 14 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 13 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 12 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 11 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 10 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 9 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 8 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 7 generations backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- 6 generations backK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- 5 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 4 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 3 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 2 generations backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- 1 generation backK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- This deviceK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −18 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −17 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −16 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −15 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −14 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −13 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −12 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −11 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −10 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −9 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −8 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −7 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| −6 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| −5 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| −4 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| −3 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| −2 | K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 | — |
| −1 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
| 0 (this device) | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
| +1 | K242486 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2025 | — |
| +2 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 16 | 0 |
| 1996 | 24 | 0 |
| 1997 | 12 | 0 |
| 1998 | 16 | 0 |
| 1999 | 17 | 0 |
| 2000 | 18 | 0 |
| 2001 | 24 | 0 |
| 2002 | 16 | 0 |
| 2003 | 17 | 0 |
| 2004 | 23 | 0 |
| 2005 | 24 | 0 |
| 2006 | 23 | 0 |
| 2007 | 16 | 0 |
| 2008 | 19 | 0 |
| 2009 | 19 | 0 |
| 2010 | 21 | 0 |
| 2011 | 10 | 0 |
| 2012 | 11 | 0 |
| 2013 | 5 | 0 |
| 2014 | 11 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K153575 | Tyber Medical Trauma ScrewSummary page 4…Product Code(s) HRS, HTN, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K153575 Tyber Medical Trauma Screw System HWC K232652 Tyber Medical Anatomical Plating System HRS Device Description Summary 21 CFR 807.9… | 2016 |
| * | K232652 | Anatomical Plating System (various)Summary page 4…ted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K153575 Tyber Medical Trauma Screw System HWC K232652 Tyber Medical Anatomical Plating System HRS Device Description Summary 21 CFR 807.92(a)(4) Note: The only subject devices of thi… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242486 | Tyber Medical Anatomical Plating System | 2025 | 1 |
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 28 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 73 of the 415 ancestors have a recall of any class.
- Of its descendants, K242486 (Tyber Medical, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K153575.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Intended Use: The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System and Ankle Fracture/Fusion System with the following indications: Indications for Use: Mini-frag System The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small…
Read the full statement (211 words)
Intended Use:
The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System and Ankle Fracture/Fusion System with the following indications:
Indications for Use:
Mini-frag System
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-Frag System is not for Spinal Use.
Ankle Fracture/Fusion System
Tyber Medical Ankle Fracture/Fusion System is indicated for Use in:
. Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, periarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
. In intra- and extra articular fractures, osteotomies, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
. In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.
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/K241218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241218: Tyber Medical Anatomical 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/K241218
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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