510(k) · Cleared
ClearedHA Coated Lag Screw
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 May 4, 2005 as substantially equivalent to K993289 (Smith & Nephew, Inc., 1999) and 3 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1995. 34 later devices descend from it.
- Decided
- May 4, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K953397 (1995). 6 ancestors in all. 34 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK953397 Hex-Fix Field FixatorSmith & Nephew Richards, Inc. · 1995
- 3 generations backK023134 Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002
- 2 generations backK023921 Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK033289 Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004
- This deviceK050849 HA Coated Lag ScrewSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 4 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on32descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953397 | Hex-Fix Field Fixator | Smith & Nephew Richards, Inc. | 1995 | — |
| −3 | K023134 | Jet-X Tin Coated Half Pins | Smith & Nephew, Inc. | 2002 | — |
| −2 | K023921 | Jet-X HA Coated Half Pins | Smith & Nephew, Inc. | 2003 | 27 |
| −1 | K033289 | Modification to Jet-X HA Coated Half Pins | Smith & Nephew, Inc. | 2004 | — |
| 0 (this device) | K050849 | HA Coated Lag Screw | Smith & Nephew, Inc. | 2005 | — |
| +1 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +2 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +3 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +4 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K993289 | Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw SystemSummary page 1…cations for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew Trauma Internal Fixation System (K993289), Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337), and Smith & Nephew Jet-X HA Coated Half Pins (1033289 a… | 1999 |
| * | K970337 | HA Global Taper (GT) Tapered Hip StemSummary page 1…composition to the following predicate devices - Smith & Nephew Trauma Internal Fixation System (K993289), Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337), and Smith & Nephew Jet-X HA Coated Half Pins (1033289 and K(023921)… | 1997 |
| * | K033289 | Modification to Jet-X HA Coated Half PinsSummary page 1…Nephew Trauma Internal Fixation System (K993289), Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337), and Smith & Nephew Jet-X HA Coated Half Pins (1033289 and K(023921) Page 1of 1 === Page 2 =… | 2004 |
| * | K023921 | Jet-X HA Coated Half PinsSummary page 1…Internal Fixation System (K993289), Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337), and Smith & Nephew Jet-X HA Coated Half Pins (1033289 and K(023921) Page 1of 1 A ~D… | 2003 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | 2013 | 33 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K123055 (Smith & Nephew, Inc., 2013) has gone furthest, with 33 descendants of its own.
- 12 other devices also cite its predicate K993289.
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 Hydroxylapatite (HA) Coated Lag Screw is used with the Compression Hip Screw Systems and intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications: Compression Hip Screws/ IMHS 1 Intracapular 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…
Read the full statement (130 words)
The Hydroxylapatite (HA) Coated Lag Screw is used with the Compression Hip Screw Systems and intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:
Compression Hip Screws/ IMHS
1 Intracapular 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 (long IMHS only)
HA Coated Lag Screws are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050849: HA Coated Lag Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050849
Report an extraction error
Are you the manufacturer?
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