510(k) · Cleared
ClearedSyntec-Taichung Non-Sterile Titanium Alloy Mini-Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntec Scientific Corp. · HRS Plate, Fixation, Bone
Cleared on Jan 27, 1999 after a 79-day review. The FDA summary names no predicate by number. 30 later devices descend from it.
- Decided
- Jan 27, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 3 citing it directly.
- This deviceK983988 Syntec-Taichung Non-Sterile Titanium Alloy Mini-PlateSyntec Scientific Corp. · 1999
- Descendant · cites it directly · 20 of its ownK023360 Leforte System Bone PlateJeil Medical Corporation · 2002
- Descendant · 2 generations on · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
- Descendant · 2 generations on · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · cites it directly · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
- Descendant · 3 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K023360Leforte System Bone PlateJeil Medical Corporation · 2002 · cites it directly20descendants
- K131311Arix Foot SystemJeil Medical Corporation · 2013 · 2 generations on9descendants
- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · 2 generations on8descendants
- K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · cites it directly7descendants
- K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983988 | Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate | Syntec Scientific Corp. | 1999 | — |
| +1 | K023360 | Leforte System Bone Plate | Jeil Medical Corporation | 2002 | — |
| +2 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| +2 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +1 | K022139 | Hip Tool Implant | Orthopedic Sciences, Inc. | 2002 | — |
| +3 | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (30)
See all 303 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?
- Of its descendants, K023360 (Jeil Medical Corporation, 2002) has gone furthest, with 20 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 titanium alloy Mini plate is provided non-sterile. The device is intended to treat fractures of various bones, including the clavicle, scapula, pelvis, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).
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/K983988 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983988: Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983988
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