510(k) · Cleared
ClearedSmith & Nephew Compression Hip Screw System, Intramedullary Hip Screw 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 Dec 20, 1999 after an 80-day review. The FDA summary names its predicate without a number. 182 later devices descend from it.
- Decided
- Dec 20, 1999
- Review
- 80 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
182 later devices descend from it, 13 citing it directly.
- This deviceK993289 Smith & Nephew Compression Hip Screw System, Intramedullary Hip…Smith & Nephew, Inc. · 1999
- Descendant · cites it directly · 121 of its ownK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- Descendant · cites it directly · 93 of its ownK072818 Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe…Smith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 77 of its ownK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 69 of its ownK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- Descendant · 3 generations on · 60 of its ownK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
Showing 5 of 182 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 182 · See all- K040212Trigen IntertanSmith & Nephew, Inc. · 2004 · cites it directly121descendants
- K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc. · 2007 · cites it directly93descendants
- K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · 2 generations on77descendants
- K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005 · 2 generations on69descendants
- K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · 3 generations on60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993289 | Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System | Smith & Nephew, Inc. | 1999 | — |
| +1 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| +1 | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | Smith & Nephew, Inc. | 2007 | — |
| +2 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| +2 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| +3 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 4 | 0 |
| 2020 | 11 | 0 |
| 2021 | 10 | 0 |
| 2022 | 10 | 0 |
| 2023 | 18 | 0 |
| 2024 | 22 | 0 |
| 2025 | 19 | 0 |
| 2026 | 14 | 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? (14)
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 |
|---|---|---|---|
| * | — | IMHS Hip Screw Systems Named without a submission number | |
| * | — | Titanium Classic Compression Hip Screw System Named without a submission number | |
| * | — | Osteotomy/Blade Plates Named without a submission number | |
| * | — | Medoff Sliding Plate Named without a submission number | |
| * | — | Biomet Compression Hip Screw System Named without a submission number | |
| * | — | Vari-Angle Hip System Named without a submission number | |
| * | — | ACE Cannulated Hip Screw System Named without a submission number | |
| * | — | Alta Modular Trauma System Named without a submission number | |
| * | — | NoLok/Keyed Compression Hip Screw System Named without a submission number | |
| * | — | Free-Lock Femoral Fixation System Named without a submission number | |
| * | — | Dynamic Hip/Condylar Screw System Named without a submission number | |
| * | — | Synthes Femoral Nail System Named without a submission number | |
| * | — | Howmedica Gamma Locking Nail System Named without a submission number | |
| * | — | Angled/Condylar/Osteotomy Blade Plates Named without a submission number |
What descends from it? (182)
See all 18213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040212 | Trigen Intertan | 2004 | 121 |
| K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | 2007 | 93 |
| K080434 | Intertan CHS Locking Plate System Prox Fem Plates/Screw | 2008 | 35 |
| K050849 | HA Coated Lag Screw | 2005 | 34 |
| K040656 | Modification to Smith & Nephew Intramedullary Hip Screw | 2004 | 9 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
| K050226 | Asian Intramedullary Hip Screw Nails | 2005 | 7 |
| K112406 | Peri-Loc Proximal Femur Locking Bone Plates | 2011 | 3 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP… | 2022 | 2 |
| K120360 | Ortho Solutions Trauma Plates for Osteosysnthesis | 2012 | 2 |
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?
- Of its descendants, K040212 (Smith & Nephew, Inc., 2004) has gone furthest, with 121 descendants of its own.
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?
The Trauma Internal Fixation System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in adult and pediatric patients are as follows: Adult indications: 1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head). 2.…
Read the full statement (167 words)
The Trauma Internal Fixation System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in adult and pediatric patients are as follows:
Adult indications:
1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head).
2. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
3. Osteotomies for patients with diseases or deformities of the hip.
4. Hip arthrodesis.
5. Supracondylar fractures and distal femoral fractures using a supracondylar plate.
6. Ipsilateral femoral shaft/neck fractures (IMHS only).
Pediatric indications:
1. Congenital coxa vara.
2. Congenital dislocation of the hip.
3. Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomeningocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
4. Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.
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/K993289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993289
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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