510(k) · Cleared
ClearedExternal Fixator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Christopher D. Endara · NDK System, External Fixator (With Metallic Invasive Components)
Cleared on Dec 20, 2012 as substantially equivalent to K101375 (TriMed, Inc., 2010) and 4 other predicates after a 148-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Dec 20, 2012
- Review
- 148 days
- Class
- Class II
- Product code
- NDK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K831576 (1983). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 3 generations backK974911 External FixatorAvanta Orthopaedics, Inc. · 1998
- 2 generations backK981716 External FixationAvanta Orthopaedics, Inc. · 1998
- 1 generation backK101375 Trimed X-FixTriMed, Inc. · 2010
- This deviceK122208 External Fixator SystemChristopher D. Endara · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −3 | K974911 | External Fixator | Avanta Orthopaedics, Inc. | 1998 | — |
| −2 | K981716 | External Fixation | Avanta Orthopaedics, Inc. | 1998 | — |
| −1 | K101375 | Trimed X-Fix | TriMed, Inc. | 2010 | — |
| 0 (this device) | K122208 | External Fixator System | Christopher D. Endara | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 NDK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101375 | Trimed X-FixSummary page 1…xation Classification: 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener Product Code: NDK Predicate Devices: K101375, K973017, K971755, K030390, and K040258 Device Description: The external fixation system includes various size components… | 2010 |
| * | K973017 | Synthes Combination Clamp and Dynamization ClipSummary page 1…lassification: 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener Product Code: NDK Predicate Devices: K101375, K973017, K971755, K030390, and K040258 Device Description: The external fixation system includes various size components… | 1997 |
| * | K971755 | Hoffmann II Compact External Fixation SystemSummary page 1…tion: 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener Product Code: NDK Predicate Devices: K101375, K973017, K971755, K030390, and K040258 Device Description: The external fixation system includes various size components… | 1997 |
| * | K030390 | Synthes Large Combination Clamp and Dynamization Clip - MR SafeSummary page 1…21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener Product Code: NDK Predicate Devices: K101375, K973017, K971755, K030390, and K040258 Device Description: The external fixation system includes various size components to accomm… | 2003 |
| * | K040258 | Synthes Medium External Fixation System-MR SafeSummary page 1….3040: Smooth or Threaded Metallic Bone Fixation Fastener Product Code: NDK Predicate Devices: K101375, K973017, K971755, K030390, and K040258 Device Description: The external fixation system includes various size components to accommodate various… | 2004 |
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 29 years and passes through 4 companies; a new generation was cleared every 12.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All NDK devicesNDK System, External Fixator (With Metallic Invasive Components): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NDK
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NDK
Too few NDK 510(k)s in any year since 2007 to give a median.
Recalls per year · NDK
No recall names NDK since 2007.
Adverse event reports per year · NDK
1in 2023
MAUDE reports naming product code NDK, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The external fixation system is a device intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122208: External Fixator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122208
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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