510(k) · Cleared
ClearedRenovis T 710 Large External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on May 11, 2011 as substantially equivalent to K861766 (Howmedica Corp., 1986) and 4 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1981. 2 later devices descend from it.
- Decided
- May 11, 2011
- Review
- 35 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K803166 (1981). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK803166 Double Ball JointHowmedica Corp. · 1981
- 1 generation backK952730 Hoffmann II External Fixation SystemHowmedica Corp. · 1995
- This deviceK110965 Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011
- Descendant · cites it directly · 0 of its ownK213905 ONX Large External Fixation SystemOrthonovis, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK171211 OIC External Fixation SystemOrthopaedic Implant Company · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K803166 | Double Ball Joint | Howmedica Corp. | 1981 | — |
| −1 | K952730 | Hoffmann II External Fixation System | Howmedica Corp. | 1995 | — |
| 0 (this device) | K110965 | Renovis T 710 Large External Fixation System | Renovis Surgical Technologies, LLC | 2011 | — |
| +1 | K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022 | — |
| +1 | K171211 | OIC External Fixation System | Orthopaedic Implant Company | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 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? (5)
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 |
|---|---|---|---|
| * | K861766 | Howmedica Hoffmann Fixation Pin SystemSummary page 1…n determined by FDA to be substantially equivalent to pre-amendment devices: Howmedica Hoffmann Fixation Pin System from Howmedica Corp. (now Stryker Corporation), K86 1766; Apex Fixation Pins from Howmedica Osteonics Corp. (now Stryker Corporation), KOI 1136; Hoffmann II External Fixation Syste… | 1986 |
| * | K011136 | Apex Fixation Pins | 2001 |
| * | K952730 | Hoffmann II External Fixation SystemSummary page 1…ation Pins from Howmedica Osteonics Corp. (now Stryker Corporation), KOI 1136; Hoffmann II External Fixation System from Howmedica Corp. (now Stryker Corporation), K952730; Synthes Adjustable Large Fixator System from Synthes (USA), K010344; and TransFx External Fixation System from Immedica, I… | 1995 |
| * | K010344 | Adjustable Large Fixator SystemSummary page 1…1136; Hoffmann II External Fixation System from Howmedica Corp. (now Stryker Corporation), K952730; Synthes Adjustable Large Fixator System from Synthes (USA), K010344; and TransFx External Fixation System from Immedica, Inc. (now Zimmer, Inc.), K984357. The intended use, design principles, m… | 2001 |
| * | K984357 | Transfx External Fixation SystemSummary page 1…ion), K952730; Synthes Adjustable Large Fixator System from Synthes (USA), K010344; and TransFx External Fixation System from Immedica, Inc. (now Zimmer, Inc.), K984357. The intended use, design principles, materials and overall dimensions of the subject and predicate devices are substantially th… | 1999 |
What descends from it? (2)
2 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?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K213905 (Orthonovis, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K861766.
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. 2011, 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 Renovis T 710 Large External Fixation System is indicated for the following:
*Stabilization/fixation of:
o Long bone fractures in tibia and femur
o Fractures of pelvis and ankle
o Peri-articular and intra-articular fractures of knee and ankle
*Joint arthrodesis
*Non-unions and mal-unions
*Osteotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110965 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110965: Renovis T 710 Large External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110965
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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