510(k) · Cleared
ClearedEbi DFS Optirom Elbow Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on May 23, 2002 as substantially equivalent to K992515 (Ebi, L.P., 1999) and 2 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- May 23, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981483 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981483 | Ebi DFS Joint Fixator, Model 02800 | Electro-Biology, Inc. | 1998 | — |
| −1 | K020403 | Modification to Ebi Xfix DFS Optirom Elbow Fixator | Ebi, L.P. | 2002 | — |
| 0 (this device) | K021312 | Ebi DFS Optirom Elbow Fixator | Ebi, L.P. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 21.4 · 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? (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 |
|---|---|---|---|
| * | K992515 | Ebi Xfix DFS Optirom Elbow FixatorSummary page 1…ultiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030. . Predicate or Legally Marketed Device: . EBI® XFIX® DFS® OptiROM® Elbow Fixator (K992515, K981483, K0202403) 4. Description of Device: The System consists of external fixation components and implantable bone screws.… | 1999 |
| * | K981483 | Ebi DFS Joint Fixator, Model 02800Summary page 1…omponent Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030. . Predicate or Legally Marketed Device: . EBI® XFIX® DFS® OptiROM® Elbow Fixator (K992515, K981483, K0202403) 4. Description of Device: The System consists of external fixation components and implantable bone screws. The EBI X… | 1998 |
| * | K020403 | Modification to Ebi Xfix DFS Optirom Elbow FixatorSummary page 2…s: The modified EBI XFIX DFS OptiROM Elbow Fixator is substantially equivalent to the following predicate device: EBI XFIX DFS OptiROM Elbow Fixator (K981483, K992515, K020403) . The additional EBI XFIX DFS OptiROM Elbow Fixator components are fabricated from the same materials as the components of the… | 2002 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K992515.
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.
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 EBI® XFIX® DFS® OptiROM® Elbow Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:
1. Fracture dislocation with ligamentos instability.
2. Comminuted intra-articular fractures.
3. Post traumatic reconstruction for joint stiffness.
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/K021312 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021312: Ebi DFS Optirom Elbow Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021312
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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