510(k) · Cleared
ClearedExternal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 7, 2018 as substantially equivalent to K162033 (Wright Medical, 2017) and 3 other predicates after a 260-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Sep 7, 2018
- Review
- 260 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K962616 (1996). 77 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 2 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 1 generation backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- This deviceK173883 External Fixation SystemLife Spine, Inc. · 2018
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 4 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 3 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 2 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 1 generation backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- This deviceK173883 External Fixation SystemLife Spine, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −4 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| −3 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| −2 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| −1 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | 2017 | 1 |
| 0 (this device) | K173883 | External Fixation System | Life Spine, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K162033 | SALVATION External Fixation SystemSummary page 5…e: Screw, Fixation, Bone Classification: KTT, CFR 888.3030, Class II Primary Predicate: Wright Medical Salvation External Fixation System (K162033) Secondary Predicate: Orthofix True Lock Ring Fixation System (K170650) Vilex Static Stabilizat… | 2017 |
| * | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0Summary page 5…30, Class II Primary Predicate: Wright Medical Salvation External Fixation System (K162033) Secondary Predicate: Orthofix True Lock Ring Fixation System (K170650) Vilex Static Stabilization System (K151881) Stryker Hoffman External Fixat… | 2017 |
| * | K151881 | X-Fix Line AdditionsSummary page 5…nal Fixation System (K162033) Secondary Predicate: Orthofix True Lock Ring Fixation System (K170650) Vilex Static Stabilization System (K151881) Stryker Hoffman External Fixation (K122284) Device Description: The Life Spine External… | 2016 |
| * | K122284 | Hoffmann 3Summary page 5…Lock Ring Fixation System (K170650) Vilex Static Stabilization System (K151881) Stryker Hoffman External Fixation (K122284) Device Description: The Life Spine External Fixation System is a component system of rings, struts, threaded rods,… | 2012 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 77 ancestors have a recall of any class.
- 1 other device also cites its predicate K162033.
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. 2018, 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 Life Spine External Fixation System is intended for Adults: Fusion of the foot including: Triple arthrodesis Isolated hindfoot arthrodesis Midfoot arthrodesis Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, MT), metatarsal cuboid Treatment of fractures including: Treatment of LisFranc fracture/dislocations in…
Read the full statement (271 words)
The Life Spine External Fixation System is intended for Adults:
Fusion of the foot including:
Triple arthrodesis
Isolated hindfoot arthrodesis
Midfoot arthrodesis
Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus,
naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, MT), metatarsal cuboid
Treatment of fractures including:
Treatment of LisFranc fracture/dislocations in diabetic and Charcot neuropathy patient
Fractures and/or comminuted fractures (open or closed) of the calcaneus, talus, cuboid, navicular, cuneiforms, and/or
metatarsals (including jones fractures), ankle and distal tibia
Additional fixation adjunct to internal fixation of the distal tibia, calcaneus, talus, navicular, cuboid, cuneiforms, and/or
metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation
Reconstruction of deformities including:
Neuropathic deformities
Charcot reconstruction with or without corrective osteotomies
Diabetic Charcot Reconstruction
Prevention and treatment of contracture of joints and tendons in equinus
Treatment of infection unions, nonunions, or malunions
Offloading and or immobilization of ulcers and/or wounds of the foot or ankle
Stabilization associated with tendon or ligament surgeries. Tendon lengthening, repairs, and transfers both deep and or
superficial around the foot and ankle including posterior tibial , tibialis anterior, flexor digitorum longus, achilles, flexor
hallucis longus, peroneus longus, extensor hallucis longus, extensor digitorum longus
Tumor and neoplasm resection and reconstruction
Stabilization associated with rotation flaps, free flaps, muscle flaps, advancement flaps, fasciocutaneous flap, split
thickness skin grafting, biological graft alternatives.
Pseudoarthrosis or non-unions of long bones.
Correction of bony or soft tissue deformities
Correction of segmental or nonsegmental bony or soft tissue defects
Use on long bones including tibia and fibula
Use with or without IM nail in the ankle in Charcot patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173883: 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/K173883
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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