510(k) · Cleared
ClearedKens Internal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kens Finemedtech Sdn. Bhd · HRS Plate, Fixation, Bone
Cleared on Jun 18, 2009 as substantially equivalent to K063020 (Intai Technology, Inc., 2006) after an 87-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Jun 18, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983495 (1998). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
- 1 generation backK063020 Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006
- This deviceK090786 Kens Internal Fixation SystemKens Finemedtech Sdn. Bhd · 2009
- Descendant · cites it directly · 0 of its ownK111008 Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K111008Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S… | Syntec Scientific Corp. | 1998 | — |
| −1 | K063020 | Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System | Intai Technology, Inc. | 2006 | — |
| 0 (this device) | K090786 | Kens Internal Fixation System | Kens Finemedtech Sdn. Bhd | 2009 | — |
| +1 | K111008 | Microware Bone Plates and Bone Screw | Microware Precision Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K063020 | Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemSummary page 1…TAI Technology Corp., INTAI bone plates and bone screw system & INTAI DHS/DCS plate system (K063020) Material: L (~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Kens FineMedTech Sdn1.B… | 2006 |
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 |
|---|---|---|---|
| K111008 | Microware Bone Plates and Bone Screw | 2012 | 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 11 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111008 (Microware Precision Co., Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063020.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE. The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges). The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for…
Read the full statement (113 words)
The devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE.
The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges).
The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
Pin and Wire are indicated for use in fracture fixation, for healing of comminuted bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090786: Kens Internal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090786
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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