510(k) · Cleared
Recalled · Class II · 2025Anatomical Plating System (various)
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 Dec 13, 2023 as substantially equivalent to K222465 (Tyber Medical, LLC, 2023) and 3 other predicates after a 104-day review. Its family tree reaches back 18 generations to 1996. 3 later devices descend from it. It has been recalled 20 times.
- Decided
- Dec 13, 2023
- Review
- 104 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 20
- Predicates
- 4
Its longest line of descent runs back 18 generations to K962616 (1996). 410 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations between
- 3 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 2 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 1 generation backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- This deviceK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023
- Descendant · cites it directly · 2 of its ownK241218 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 18 generations
- Root · 18 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 17 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 16 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 15 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 14 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 13 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 12 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 11 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 10 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 9 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 8 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 7 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 6 generations backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- 5 generations backK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- 4 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 3 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 2 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 1 generation backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- This deviceK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023
Most influential descendants
Showing 3 of 3 · See all- K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · cites it directly2descendants
- K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025 · cites it directly1descendant
- K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −17 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −16 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −15 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −14 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −13 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −12 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −11 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −10 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −9 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −8 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −7 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −6 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| −5 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| −4 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| −3 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| −2 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| −1 | K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 | — |
| 0 (this device) | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | — |
| +1 | 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 | 15 | 0 |
| 1999 | 17 | 0 |
| 2000 | 18 | 0 |
| 2001 | 24 | 0 |
| 2002 | 15 | 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 | 10 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K222465 | Tyber Medical Anatomical Plating SystemSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K222465 11 Anatomical Plating System 11 HRS I K203817/K… | 2023 |
| * | K203817 | Tyber Medical Anatomical Plating SystemSummary page 5…Product Code I K222465 11 Anatomical Plating System 11 HRS I K203817/K193222 11 Anatomical Plating System 11 HRS I K213591… | 2021 |
| * | K193222 | Tyber Medical Anatomical Plating SystemSummary page 5…Product Code I K222465 11 Anatomical Plating System 11 HRS I K203817/K193222 11 Anatomical Plating System 11 HRS I K213591… | 2020 |
| * | K213591 | ANTHEM® Fracture SystemSummary page 5…11 HRS I K203817/K193222 11 Anatomical Plating System 11 HRS I K213591 11 Anthem Fracture System 11 HRS Device Des… | 2022 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2025 | Class II | Z-1132-2026 | Process control | The supplier manufactured anatomical left plates with an incorrect thread orientation. |
| Dec 19, 2025 | Class II | Z-1131-2026 | Process control | The supplier manufactured anatomical left plates with an incorrect thread orientation. |
| Jan 21, 2025 | Class II | Z-1214-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1220-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1211-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1225-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1218-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1212-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1210-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1217-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1209-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1222-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1216-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1219-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1224-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1226-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1221-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1215-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1223-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
| Jan 21, 2025 | Class II | Z-1213-2025 | Process control | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 72 of the 410 ancestors have a recall of any class.
- Of its descendants, K241218 (Tyber Medical, LLC, 2024) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K222465.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System, Foot System, Long Bone Fracture System, and Ankle Fracture/ Fusion System with the following indications: 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 (317 words)
The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System, Foot System, Long Bone Fracture System, and Ankle Fracture/ Fusion System with the following indications:
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.
Foot System
The Tyber Medical Foot System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone in the foot (Phalanges and Metatarsals), and long bones and long bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) in an adult patient. The Tyber Medical Foot System is not for Spinal Use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula. The Tyber Medical Long Bone Fracture 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, nonunions, 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 as stated in the FDA summary.
https://510kreport.com/device/K232652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232652: Anatomical Plating System (various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232652
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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