510(k) · Cleared
ClearedNewfix External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technologia Y Diseno Industrial, S.A DE C.V · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 14, 2011 as substantially equivalent to K831576 (Electro-Biology, Inc., 1983) and 10 other predicates after a 306-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Mar 14, 2011
- Review
- 306 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 8 generations to K962823 (1996). 52 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 1 generation backK101254 Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2010
- This deviceK101338 Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −1 | K101254 | Newfix Screw, Wire and Pin Fixarion System | Tecnologia Y Diseno Industrial, S.A DE C.V | 2010 | — |
| 0 (this device) | K101338 | Newfix External Fixation System | Technologia Y Diseno Industrial, S.A DE C.V | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (11)
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 |
|---|---|---|---|
| * | K831576 | OrthofixSummary page 2…Manuactuer ad PrductProduct Orthofix Modulsystem Dynamic Axial Fixation System K831 576, k955845 K961350,1k011034, Synthes ® E… | 1983 |
| * | K955848 | Orthofix Modulsystem Our reading of the summary gave K955845, FDA’s number for LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens (Surgical Image Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Orthofix Modulsystem Dynamic Axial Fixation System”. | 1996 |
| * | K961350 | Synthes Mini External FixatorSummary page 2…Modulsystem Dynamic Axial Fixation System K831 576, k955845 K961350,1k011034, Synthes ® External Fixation System k090658 Extrafix Extern… | 1996 |
| * | K011034 | Synthes (Usa) Medium External Fixation SystemSummary page 2…em Dynamic Axial Fixation System K831 576, k955845 K961350,1k011034, Synthes ® External Fixation System k090658 Extrafix External fixati… | 2001 |
| * | K090658 | Synthes External Fixation Devices, MR ConditionalSummary page 2…K961350,1k011034, Synthes ® External Fixation System k090658 Extrafix External fixation System by QFX Technologies k091258 Smith & Nephew Externa… | 2010 |
| * | K091258 | Extrafix External Fixation SystemSummary page 2…External Fixation System k090658 Extrafix External fixation System by QFX Technologies k091258 Smith & Nephew External Fixation System K994143 Hoffmann 11Compact Ext… | 2009 |
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 2…ernal fixation System by QFX Technologies k091258 Smith & Nephew External Fixation System K994143 Hoffmann 11Compact External Fixation System K971755 Zimmer Wristore Distal… | 2000 |
| * | K971755 | Hoffmann II Compact External Fixation SystemSummary page 2…ew External Fixation System K994143 Hoffmann 11Compact External Fixation System K971755 Zimmer Wristore Distal Radius Fracture Fixator k012294 Tecnologia y Diseiho I… | 1997 |
| * | K012294 | Wristore FixatorSummary page 2…ompact External Fixation System K971755 Zimmer Wristore Distal Radius Fracture Fixator k012294 Tecnologia y Diseiho Industrial (TDI) Newfix Screw, Wire, and K101254 Fixation System… | 2002 |
| * | K101254 | Newfix Screw, Wire and Pin Fixarion System Cleared while this submission was under review Summary page 2…ore Distal Radius Fracture Fixator k012294 Tecnologia y Diseiho Industrial (TDI) Newfix Screw, Wire, and K101254 Fixation System Treu-Instrumente GmbH Bone Fixation Screws and Pins K083912… | 2010 |
| * | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsSummary page 2…DI) Newfix Screw, Wire, and K101254 Fixation System Treu-Instrumente GmbH Bone Fixation Screws and Pins K083912 Page 2 of 6 === Page… | 2009 |
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 15 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 52 ancestors have a recall of any class.
- 5 other devices also cite its predicate K831576.
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 Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101338: Newfix 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/K101338
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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