# K050849: HA Coated Lag Screw

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 4, 2005 after 30 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953397 (1995). 6 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 1.
- K970337: HA Global Taper (GT) Tapered Hip Stem, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K033289: Modification to Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2004) Summary page 1.
- K023921: Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K050849
Methodology: https://510kreport.com/methodology