510(k) · Cleared
ClearedExalta Proximal Tibia 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 Jun 12, 2026 as substantially equivalent to K233017 (Tyber Medical, LLC, 2023) and 2 other predicates after a 60-day review. Its family tree reaches back 21 generations to 1996.
- Decided
- Jun 12, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K962616 (1996). 542 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 21 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 17 generations between
- 3 generations backK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- 2 generations backK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- 1 generation backK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
- This deviceK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
Show all 21 generations
- Root · 21 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 20 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 19 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 18 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 17 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 16 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 15 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 14 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 13 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 12 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 11 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 10 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 9 generations backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- 8 generations backK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- 7 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 6 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 5 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 4 generations backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- 3 generations backK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- 2 generations backK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- 1 generation backK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
- This deviceK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −20 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −19 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −18 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −17 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −16 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −15 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −14 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −13 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −12 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −11 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −10 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −9 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| −8 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| −7 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| −6 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| −5 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| −4 | K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 | — |
| −3 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
| −2 | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
| −1 | K242486 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2025 | — |
| 0 (this device) | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 20 | 0 |
| 1996 | 28 | 0 |
| 1997 | 13 | 0 |
| 1998 | 18 | 0 |
| 1999 | 20 | 0 |
| 2000 | 21 | 0 |
| 2001 | 31 | 0 |
| 2002 | 25 | 0 |
| 2003 | 18 | 0 |
| 2004 | 25 | 0 |
| 2005 | 29 | 0 |
| 2006 | 36 | 0 |
| 2007 | 21 | 0 |
| 2008 | 25 | 0 |
| 2009 | 24 | 0 |
| 2010 | 27 | 0 |
| 2011 | 16 | 0 |
| 2012 | 14 | 0 |
| 2013 | 7 | 0 |
| 2014 | 17 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2023 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K233017 | TM Plating SystemSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233017 TM Plating System HRS K090877… | 2023 |
| * | K090877 | Proximal Tibia Locking Plate Standard and Large, 3.5MM Low Profile and Multidirectional…Summary page 5…Product Code K233017 TM Plating System HRS K090877 A.L.P.S. Proximal Tibia Plating System HRS K242486… | 2009 |
| * | K242486 | Tyber Medical Anatomical Plating SystemSummary page 5…HRS K090877 A.L.P.S. Proximal Tibia Plating System HRS K242486 Tyber Medical Anatomical Plating System HRS Device Descri… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 96 of the 542 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Exalta Proximal Tibia Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories: I. Complete Articular – The Exalta Proximal Tibia Plating System is indicated for the treatment of nonunions, malunions, osteotomies, and fractures of the femur and tibia. This includes simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of…
Read the full statement (229 words)
The Exalta Proximal Tibia Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories:
I. Complete Articular – The Exalta Proximal Tibia Plating System is indicated for the treatment of nonunions, malunions, osteotomies, and fractures of the femur and tibia. This includes simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, periprosthetic, and fractures with associated shaft fractures.
II. Partial Articular – The partial articular (also called buttress or anti-glide) proximal tibia plates are indicated for stabilization and reduction of proximal tibia fragments and treatment of partial articular fractures of the proximal tibia (AO/OTA Fracture Classifications Type B). The partial articular straight plates are indicated for stabilization and reduction of long bone fragments and partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.
III. Mini-Frag -- The Exalta Proximal Tibia Plating System is indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of short bones and small bone fragments of bone, including, but not limited to, the hand, wrist, foot, and ankle. The Exalta Proximal Tibia Plating System is also intended for reduction and stabilization of non-load bearing long bone fragments. The Exalta Proximal Tibia Plating System is not for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261207: Exalta Proximal Tibia 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/K261207
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026