(30 days)
Not Found
No
The document describes a mechanical implant (lag screw) and its intended use in orthopedic surgery. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing.
No.
The device is a metallic screw used for orthopedic fixation, providing structural support rather than directly treating a disease or condition.
No
The device description indicates that the HA Coated Lag Screws are "large metallic screw devices that are used in conjunction with Compression Hip Screw Systems and Intramedullary Hip Screw Systems to obtain purchase inside the femoral head or condyles to help provide support for compression of the fracture." This specifies a therapeutic, fixation function, not a diagnostic one.
No
The device description clearly states it is a "large metallic screw device" made from "316L stainless steel or Titanium-6Al-4V metal materials," indicating it is a physical hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to fix bone fractures and deformities in the hip and femur. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a metallic screw designed for mechanical support within the body. This aligns with a surgical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Hydroxyapatite (HA) Coated Lag Screws are used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:
Compression Hip Screws/ IMHS
- 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.)
- Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
- Osteotomies for patients with diseases or deformities of the hip.
- Hip arthrodesis.
- Supracondylar fractures and distal femoral fractures using a supracondylar plate.
- Ipsilateral femoral shaft/neck fractures (long IMHS only).
HA Coated Lag Screws are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
HA (Hydroxylapatite) Coated Lag Screws are large metallic screw devices that are used in conjunction with Compression Hip Screw Systems and Intramedullary Hip Screw Systems to obtain purchase inside the femoral head or condyles to help provide support for compression of the fracture. HA Coated Lag Screws are available in various sizes made from either 316L stainless steel or Titanium-6Al-4V metal materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, condyles, hip
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A review of the mechanical test data indicated that the HA Coated Lag Screws are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Smith & Nephew Trauma Internal Fixation System (K993289), Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337), Smith & Nephew Jet-X HA Coated Half Pins (K033289 and K023921)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effe
Contact Person and Address
MAY - 4 2005 Pate of Summary: April 1, 2005
David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-6487
Name of Device: HA Coated Lag Screws Common Name: Lag Screws
Device Description
HA (Hydroxylapatite) Coated Lag Screws are large metallic screw devices that are used in conjunction with Compression Hip Screw Systems and Intramedullary Hip Screw Systems to obtain purchase inside the femoral head or condyles to help provide support for compression of the fracture. HA Coated Lag Screws are available in various sizes made from either 316L stainless steel or Titanium-6Al-4V metal materials.
Device Classification
21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories - Class II
Mechanical and Clinical Data
A review of the mechanical test data indicated that the HA Coated Lag Screws are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Indications for Use
The Hydroxyapatite (HA) Coated Lag Screws are used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:
Compression Hip Screws/ IMHS
- Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to 1. select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
-
- Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
-
- Osteotomies for patients with diseases or deformities of the hip.
-
- Hip arthrodesis.
- Supracondylar fractures and distal femoral fractures using a supracondylar plate. ട്.
- Ipsilateral femoral shaft/neck fractures (long IMHS only). 6.
Substantial Equivalence Information
Substantial equivalence of the HA Coated Lag Screw is based on its similarities in indications 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 (K033289 and K023921).
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2005
Mr. David Henley Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc. Orthopaedics Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K050849
Trade/Device Name: HA Coated Lag Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 1, 2005 Received: April 4, 2005
Dear Mr Henley:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have reviewe a your we determined the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass backed in 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nu v ooth rot do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good eonly of provisions see, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be may be subject to saon adam Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r was oo advisor and a determination that your device complies with other requirements of the Act or that Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); an the Ave of equirements) ; good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 800); gover 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough inding of substantial equivalence of your device to a legally premaired notification: "The Privation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director
Division of General, Restorative
and Neurological Devices
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Indications for Use Statement
510(k) Number (if known): _
HA Coated Lag Screws Device Name:
Indications for Use:
The Hydroxylapatite (HA) Coated Lag Screw is used with the Compression Hip Screw Systems rrie Tyuloxytapulle In A Seated Signers in adult patients for the following indications:
Compression Hip Screws/ IMHS
- Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more 1. infliatapular fractures of the sembled of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
- a avascular necrosis or the lombratives with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
- Osteotomies for patients with diseases or deformities of the hip. 3.
- Hip arthrodesis. 4.
- r lip at frirousers: ട്.
- ipsilateral femoral shaft/neck fractures (long IMHS only) 6.
HA Coated Lag Screws are for single use only.
| Prescription Use
| (Part 21 CFR 801, 109) | X |
|---|---|
| -------------------------------------------- | --- |
and/or
| Over-The-Counter Use
| (Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
(Please do not write Below THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styp Rhodes
Division of Gener A Restorative. and Neurological Devic
510(k) Number K050849