510(k) · Cleared
ClearedTotal Compression Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on Dec 5, 2014 as substantially equivalent to K094037 (Ortho-Pro, LLC, 2010) and 2 other predicates after a 45-day review. Its family tree reaches back 10 generations to 1996. 24 later devices descend from it.
- Decided
- Dec 5, 2014
- Review
- 45 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K954385 (1996). 52 ancestors in all, the oldest K895117 (1990). 24 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- This deviceK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 23 of its ownK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- Descendant · 3 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 4 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · 4 generations on · 3 of its ownK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
Show all 10 generations
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 8 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 7 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 6 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 5 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 4 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- This deviceK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015 · cites it directly23descendants
- K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · 2 generations on22descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 3 generations on10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 4 generations on9descendants
- K232652Anatomical Plating System (various)Tyber Medical, LLC · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −9 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −8 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −7 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −6 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −5 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −4 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −3 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −2 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −1 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| 0 (this device) | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K151442 | Total Compression Plating (TCP) System | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| +3 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +4 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +4 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K094037 | TC Plating SystemSummary page 4…sification Name and Reference: 21 CFR 888.3030- Class II Device Product Code, Device Panel: HRS - Orthopedic 3. Predicate Device: K094037 TC Plating System K121651 ORTHOLOCTM 3Di Midfoot/Flatfoot System K12035… | 2010 |
| * | K121651 | Ortholoc 3DI Midfoot/Flatfoot SystemSummary page 4…30- Class II Device Product Code, Device Panel: HRS - Orthopedic 3. Predicate Device: K094037 TC Plating System K121651 ORTHOLOCTM 3Di Midfoot/Flatfoot System K120359 ORTHOLOCTM 3Di Hallux System 4. Device Descriptio… | 2012 |
| * | K120359 | Ortholoc 3DI Hallux SystemSummary page 4…opedic 3. Predicate Device: K094037 TC Plating System K121651 ORTHOLOCTM 3Di Midfoot/Flatfoot System K120359 ORTHOLOCTM 3Di Hallux System 4. Device Description The TOTAL COMPRESSION PLATING SYSTEM is comprised of a variety of… | 2012 |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151442 | Total Compression Plating (TCP) System | 2015 | 23 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 13 of the 52 ancestors have a recall of any class.
- Of its descendants, K151442 (Wrightmedicaltechnologyinc, 2015) has gone furthest, with 23 descendants of its own.
- 2 other devices also cite its predicate K094037.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 TC Plating System is intended for essentially non-load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe and pelvis. Specific examples of use in the foot include: Mid / Flatfoot Fusions • LisFranc Arthrodesis and/or Stabilization • 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT)…
Read the full statement (161 words)
The TC Plating System is intended for essentially non-load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe and pelvis.
Specific examples of use in the foot include:
Mid / Flatfoot Fusions
• LisFranc Arthrodesis and/or Stabilization
• 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
• Medial Column Fusion
First metatarsal osteotomies for hallux valgus correction including:
• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
First metatarsal fracture fixation
Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143025: Total Compression 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/K143025
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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