510(k) · Cleared
ClearedTECHFIT Patient-Specific Maxillofacial System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Industrias Medicas Sampedro S.A.S · JEY Plate, Bone
Cleared on May 19, 2021 as substantially equivalent to K191028 (KLS-Martin L.P., 2019) after a 194-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- May 19, 2021
- Review
- 194 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954385 (1996). 14 ancestors in all, the oldest K943347 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 4 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 3 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 2 generations backK163579 KLS Martin Individual Patient SolutionsKLS Martin L.P. · 2017
- 1 generation backK191028 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2019
- This deviceK203282 TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S · 2021
- Descendant · cites it directly · 0 of its ownK220199 AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −5 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −4 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −3 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −2 | K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017 | — |
| −1 | K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019 | — |
| 0 (this device) | K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | 2021 | — |
| +1 | K220199 | AFFINITY Proximal Tibia System | Techfit Digital Surgery, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 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? (1)
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 |
|---|---|---|---|
| * | K191028 | KLS Martin Individual Patient SolutionsSummary page 4…II Product Code: JEY Regulation Number: 21 CFR 872.4760 Primary Predicate: KLS Martin Individual Patient Solutions (K191028) Reference Devices: AFFINITY – Variable Angle Distal Radius System (K191641) KLS Mart… | 2019 |
| † | K191641 | AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius… | 2019 |
| † | K032442 | KLS-Martin Mandibular/Reconstruction System II | 2003 |
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 |
|---|---|---|---|
| K220199 | AFFINITY Proximal Tibia System | 2022 | 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 25 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K220199 (Techfit Digital Surgery, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K191028.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.
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/K203282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203282: TECHFIT Patient-Specific Maxillofacial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203282
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