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 Mar 19, 2025 as substantially equivalent to K232652 (Tyber Medical, LLC, 2023) and 3 other predicates after a 210-day review. Its family tree reaches back 20 generations to 1996. 1 later device descends from it.
- Decided
- Mar 19, 2025
- Review
- 210 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K962616 (1996). 417 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 16 generations between
- 3 generations backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- 2 generations backK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- 1 generation backK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- This deviceK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
- Descendant · cites it directly · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
Show all 20 generations
- Root · 20 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 19 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 18 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 17 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 16 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 15 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 14 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 13 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 12 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 11 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 10 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 9 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 8 generations backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- 7 generations backK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- 6 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 5 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 4 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 3 generations backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- 2 generations backK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- 1 generation backK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- This deviceK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −19 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −18 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −17 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −16 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −15 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −14 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −13 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −12 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −11 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −10 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −9 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −8 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| −7 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| −6 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| −5 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| −4 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| −3 | K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 | — |
| −2 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
| −1 | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
| 0 (this device) | K242486 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2025 | — |
| +1 | 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K232652 | Anatomical Plating System (various)Summary page 6…21 CFR 807 .92(a)(4) This traditional 510(k) is a line extension to the Tyber Medical Anatomical Plating System previously cleared under K232652, K241218, and K233423/K222465. The line extension includes additional plates, screws, washers, trays, and instrumentation to the… | 2023 |
| * | K241218 | Tyber Medical Anatomical Plating SystemSummary page 6…21 CFR 807 .92(a)(4) This traditional 510(k) is a line extension to the Tyber Medical Anatomical Plating System previously cleared under K232652, K241218, and K233423/K222465. The line extension includes additional plates, screws, washers, trays, and instrumentation to the Tyber Me… | 2024 |
| * | K233423 | Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemSummary page 6…_ _t o m _ _ na _ _l A I K233423 /K222465 11 TyberMedical Anat om ical Platin g Sy stem… | 2023 |
| * | K222465 | Tyber Medical Anatomical Plating SystemSummary page 6…_ _t o m _ _ na _ _l A I K233423 /K222465 11 TyberMedical Anat om ical Platin g Sy stem… | 2023 |
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 |
|---|---|---|---|
| K261207 | Exalta Proximal Tibia Plating System | 2026 | 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 29 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 73 of the 417 ancestors have a recall of any class.
- Of its descendants, K261207 (Tyber Medical, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K232652.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. Indications for Use: Mini-Frag System The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion 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…
Read the full statement (191 words)
Intended Use:
The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing.
Indications for Use:
Mini-Frag System
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion 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
The Tyber Medical Ankle Fracture/Fusion System is indicated for use in:
* Fixation of fractures of the distal tibia including, 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 non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
* In distal tibia/fibula long bones which include the metaphyseal and diaphyseal region of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion System is not for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242486: 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/K242486
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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