510(k) · Cleared
ClearedBfix Orthopedic External Fixator Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aike (Shanghai) Medical Instrument Co., Ltd. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 5, 2021 as substantially equivalent to K113770 (Orthofix Srl, 2012) after a 312-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Jan 5, 2021
- Review
- 312 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831576 (1983). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 2 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 1 generation backK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · Recalled
- This deviceK200491 Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −2 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −1 | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | 13 |
| 0 (this device) | K200491 | Bfix Orthopedic External Fixator Systems | Aike (Shanghai) Medical Instrument Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 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 |
|---|---|---|---|
| * | K113770 | Orthofix Galaxy Fixation SystemSummary page 4…888.3030 Regulatory Class: Class II Product code: KTT Review Panel Orthopedic III. Predicate Devices Predicate device 1 510(k) Number: K113770 Product Code: KTT Classification: 21 CFR 888.3030 Trade Name: Orthofix Galaxy Fixation System Common Name: External Fixation Devi… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 4 companies; a new generation was cleared every 12.8 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113770.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs.
The indication for use includes:
- open or closed fractures in long bones;
- bone defects or reconstructive procedure
- limb lengthening
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200491: Bfix Orthopedic External Fixator Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200491
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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