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 Aug 13, 2021 as substantially equivalent to K193222 (Tyber Medical, LLC, 2020) and 4 other predicates after a 227-day review. Its family tree reaches back 15 generations to 1996. 10 later devices descend from it.
- Decided
- Aug 13, 2021
- Review
- 227 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K954385 (1996). 238 ancestors in all, the oldest K792022 (1979). 10 later devices descend from it, 4 citing it directly.
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 2 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 1 generation backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- This deviceK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · cites it directly · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · cites it directly · 3 of its ownK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- Descendant · cites it directly · 2 of its ownK233423 Tyber Medical Anatomical Plating System – Line extension to the…Tyber Medical, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
Show all 15 generations
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 13 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 12 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 11 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 10 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 9 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 8 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 7 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 6 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 2 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 1 generation backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- This deviceK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · cites it directly9descendants
- K232652Anatomical Plating System (various)Tyber Medical, LLC · 2023 · cites it directly3descendants
- K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · 2 generations on2descendants
- K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC · 2023 · cites it directly2descendants
- K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −14 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −13 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −12 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −11 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −10 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −9 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −8 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −7 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −6 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −2 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −1 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| 0 (this device) | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +1 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +1 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
| +2 | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
| +1 | K233423 | Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System | Tyber Medical, LLC | 2023 | — |
| +2 | K242486 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 13 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 13 | 0 |
| 2001 | 14 | 0 |
| 2002 | 14 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 15 | 0 |
| 2006 | 16 | 0 |
| 2007 | 11 | 0 |
| 2008 | 12 | 0 |
| 2009 | 13 | 0 |
| 2010 | 13 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K193222 | Tyber Medical Anatomical Plating SystemSummary page 5…Additional Predicates Mini-frag/Small Bone Tyber Medical Anatomical Plating ORTHOLOC® 3Di Small Bones Plating System System (K193222) (K163039) Foot System Tyber Medical Anatomical Plating ORTHOLOC® 3Di Foot Plating Reconstructio… | 2020 |
| * | K163039 | ORTHOLOC® 3Di Small Bones PlatingSummary page 5…dicates Mini-frag/Small Bone Tyber Medical Anatomical Plating ORTHOLOC® 3Di Small Bones Plating System System (K193222) (K163039) Foot System Tyber Medical Anatomical Plating ORTHOLOC® 3Di Foot Plating Reconstruction System… | 2017 |
| * | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction SystemSummary page 5…Foot System Tyber Medical Anatomical Plating ORTHOLOC® 3Di Foot Plating Reconstruction System System (K193222) (K152974) Long Bone Fracture Tyber Medical Anatomical Plating AxSOS 3 Ti; Stryker Plating System (K162439) System… | 2015 |
| * | K162439 | AxSOS 3 Ti; Stryker Plating SystemSummary page 5…tem System (K193222) (K152974) Long Bone Fracture Tyber Medical Anatomical Plating AxSOS 3 Ti; Stryker Plating System (K162439) System System (K193222) Ankle Fracture/Fusion Tyber Medical Anatomical Plating Baby Gorilla/Gorilla Plati… | 2017 |
| * | K190365 | Baby Gorilla/Gorilla Plating SystemSummary page 5…ryker Plating System (K162439) System System (K193222) Ankle Fracture/Fusion Tyber Medical Anatomical Plating Baby Gorilla/Gorilla Plating System (190365) System System (K193222) System Primary Predicate Reference Predicates Sc… | 2019 |
| † | K133842 | Tyber Medical Trauma Screw | 2014 |
What descends from it? (10)
4 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)
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 25 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 48 of the 238 ancestors have a recall of any class.
- Of its descendants, K222465 (Tyber Medical, LLC, 2023) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K193222.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments togethet to facilitate healing and is composed of the following bone plate categories: Mini-frag/Small Bone System The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments including, but are not limited to, the hand, wrist, foot…
Read the full statement (307 words)
The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments togethet to facilitate healing and is composed of the following bone plate categories:
Mini-frag/Small Bone System
The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments including, but are not limited to, the hand, wrist, foot and ankle.
The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use.
Foot System
The Tyber Medical Foot System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals), and medium/ large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of small, medium and large bones, revision surgeries and replantations 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 intended for osteotomies and non-unions, fixation of fractures 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
The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
2). 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;
3). 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/K203817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203817: 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/K203817
Report an extraction error
Are you the manufacturer?
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