510(k) · Cleared
ClearedIiizarov Pulley System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 7, 2004 as substantially equivalent to K870961 (Richards Medical Co., Inc., 1987) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1987. 8 later devices descend from it.
- Decided
- Oct 7, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870961 (1987). 2 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK870961 Richards External Fixation SystemRichards Medical Co., Inc. · 1987
- This deviceK042436 Iiizarov Pulley SystemSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
- Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
- Descendant · 2 generations on · 0 of its ownK253202 Hoffmann LRF SystemStryker GmbH · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly6descendants
- K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew · 2020 · cites it directly5descendants
- K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 2 generations on0descendants
- K253202Hoffmann LRF SystemStryker GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870961 | Richards External Fixation System | Richards Medical Co., Inc. | 1987 | — |
| 0 (this device) | K042436 | Iiizarov Pulley System | Smith & Nephew, Inc. | 2004 | — |
| +1 | K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | Smith & Nephew, Inc. | 2012 | — |
| +1 | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator… | Smith & Nephew | 2020 | — |
| +2 | K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
| +2 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
| +2 | K253202 | Hoffmann LRF System | Stryker GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K870961 | Richards External Fixation SystemSummary page 2…nt stiffness). SUBSTANTIAL EQUIVALENCE INFORMATION: The Ilizarov Pulley System is similar to the Smith & Nephew (formerly Richards) External Fixation System (llizarov) (K870961) and Smith & Nephew External Fixation System (K994143) in that all the devices are used for the same indications and consist of h… | 1987 |
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 2…he Ilizarov Pulley System is similar to the Smith & Nephew (formerly Richards) External Fixation System (llizarov) (K870961) and Smith & Nephew External Fixation System (K994143) in that all the devices are used for the same indications and consist of half pins, wires, rings and various components to const… | 2000 |
| Kept off the family tree | K87516 | Smith & Nephew Orthopaedic Cable System Number could not be read Summary page 2…port the bone segment. The Ilizarov Pulley System includes a stainless steel cable. The stainless steel cable is similar to the Smith & Nephew Orthopaedic Cable System (K87516) in that both cables are made of stainless steel and the diameters are similar (1.5mm). The Ilizarov Pulley System cable is longe… |
What descends from it? (8)
3 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?
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.
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?
External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient's need. These devices are modular, therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications: 1. Post-Traumatic joint contracture which has resulted in loss of range of…
Read the full statement (254 words)
External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient's need. These devices are modular, therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications:
1. Post-Traumatic joint contracture which has resulted in loss of range of motion
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-XTh Fixator)
6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis
9. Infected fractures or nonunions
10. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius.
11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints, as well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia.
The indications for use listed above cover many of the external fixation systems marketed by Smith & Nephew, The indications for the Ilizarov Pulley System are pseudoarthrosis of long bones, included as number 4 above. These indications are similar to the indications of the predicate devices. The device is intended for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042436: Iiizarov Pulley System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042436
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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