510(k) · Cleared
ClearedOIC External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopaedic Implant Company · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 27, 2017 as substantially equivalent to K110965 (Renovis Surgical Technologies, LLC, 2011) and 4 other predicates after a 155-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Sep 27, 2017
- Review
- 155 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K803166 (1981). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK803166 Double Ball JointHowmedica Corp. · 1981
- 2 generations backK952730 Hoffmann II External Fixation SystemHowmedica Corp. · 1995
- 1 generation backK110965 Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011
- This deviceK171211 OIC External Fixation SystemOrthopaedic Implant Company · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K803166 | Double Ball Joint | Howmedica Corp. | 1981 | — |
| −2 | K952730 | Hoffmann II External Fixation System | Howmedica Corp. | 1995 | — |
| −1 | K110965 | Renovis T 710 Large External Fixation System | Renovis Surgical Technologies, LLC | 2011 | — |
| 0 (this device) | 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 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K110965 | Renovis T 710 Large External Fixation SystemSummary page 4…nts rigidly in place. The pins are offered in various lengths and thicknesses. Comparison of Technological Characteristics (Substantial Equivalence): Predicate devices: K110965 Renovis T 710 Large External Fixation System K072212 Jet-X Bar System Clamps, Bars and Posts – MR Conditional K952730 Hoffman II… | 2011 |
| * | K072212 | Jet-X Bar System Clamps, Bars and Posts-MR SafeSummary page 4…lengths and thicknesses. Comparison of Technological Characteristics (Substantial Equivalence): Predicate devices: K110965 Renovis T 710 Large External Fixation System K072212 Jet-X Bar System Clamps, Bars and Posts – MR Conditional K952730 Hoffman II External Fixation System K061493 Apex Pins K031428 Sy… | 2008 |
| * | K952730 | Hoffmann II External Fixation SystemSummary page 4…stics (Substantial Equivalence): Predicate devices: K110965 Renovis T 710 Large External Fixation System K072212 Jet-X Bar System Clamps, Bars and Posts – MR Conditional K952730 Hoffman II External Fixation System K061493 Apex Pins K031428 Synthes Large External Fixation Clamps The OIC External Fixation Sy… | 1995 |
| * | K061493 | Apex PinsSummary page 4…evices: K110965 Renovis T 710 Large External Fixation System K072212 Jet-X Bar System Clamps, Bars and Posts – MR Conditional K952730 Hoffman II External Fixation System K061493 Apex Pins K031428 Synthes Large External Fixation Clamps The OIC External Fixation System has the following similarities to those… | 2006 |
| * | K031428 | Synthes (Usa) Large External Fixation Clamps-MR SafeSummary page 4…novis T 710 Large External Fixation System K072212 Jet-X Bar System Clamps, Bars and Posts – MR Conditional K952730 Hoffman II External Fixation System K061493 Apex Pins K031428 Synthes Large External Fixation Clamps The OIC External Fixation System has the following similarities to those which previously… | 2003 |
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 36 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K110965.
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. 2017, 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 OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.
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/K171211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171211: OIC External 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/K171211
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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