(53 days)
Not Found
No
The device description and intended use are for a physical interference screw used in surgical procedures, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as being used for the "reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries" and in various other procedures to repair or reconstruct tissues. These actions are therapeutic as they treat or alleviate a medical condition (tissue damage or instability).
No
The device is described as an interference screw used for the reattachment of tissues during surgical procedures. Its intended use is therapeutic, not diagnostic.
No
The device description and intended use clearly describe a physical interference screw used for surgical reattachment, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that the Smith & Nephew BIOSURE PK Interference Screws are used for the reattachment of tissues during surgical procedures. This is a direct surgical intervention, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Information: The information provided does not mention any diagnostic purpose, analysis of biological samples, or generation of diagnostic results.
Therefore, the Smith & Nephew BIOSURE PK Interference Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures:
Knee
- ACL Repairs
- PCL Repairs
- Extra-capsular repairs
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
- Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
- Iliotibial band tenodesis
Shoulder
- Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Acromilavicular separation repairs
- Deltoid repairs
- Rotator cuff tear repairs
- Biceps tenodesis
Foot and Ankle
- Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstructions
- Bunionectomy
- Flexor Hullucis Longus (FLH).
- Tendon Transfers
Elbow, Wrist, and Hand
- Biceps tendon reattachment
- Ulnar or radial collateral ligament reconstructions
- Lateral epicondylitis repair
- Scapholunate ligament reconstruction
- Tendon Transfers
- Carpometacarpal Joint Arthroplasty
- Carpal Ligament Reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
Reattachment of ligament, tendon, soft tissue, or bone in, shoulder, foot/ankle, knee, elbow and hand/wrist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, foot/ankle, elbow, hand/wrist
Indicated Patient Age Range
Not Found
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)
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew Biosure PK Interference Screw are substantially equivalent to the Smith & Nephew BIOSURE HA Screw, the Smith & Nephew BioRaptor 2.3PK and the Arthrex Interference Screw.
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SECTION IV
JAN 3 0 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew Biosure PK Interference Screw
Date Prepared: December 5, 2008
- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Christina Flores
Regulatory Affairs Specialist II
T 508-261-3705
F 508-261-3620
C. Device Name
Trade Name: Biosure PK Interference Screw
Common Name: Screw, Fixation, Bone
Classification Name: fixation fastener
21 CFR 888.3040 - Smooth or threaded metallic bone
Predicate Devices D.
The Smith & Nephew Biosure PK Interference Screw is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew BIOSURE HA Interference Screw (K080358), Smith & Nephew BioRaptor 2.3PK Suture Anchor (K071586), and Arthrex Interference Screw (K062466)
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K083635 2/3
We are smith&nephew
E. Description of Device
Reattachment of ligament, tendon, soft tissue, or bone in, shoulder, foot/ankle, knee, elbow and hand/wrist.
F. Intended Use
The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 25 mm or less are also intended for use in the following procedures:
Knee
- ACL Repairs .
- PCL Repairs .
- Extra-capsular repairs .
- Medial collateral ligament -
- --Lateral collateral ligament
- Posterior oblique ligament l
- Patellar realignment and tendon repairs ●
- Vastus medialis obliquous advancement
- Iliotibial band tenodesis
Shoulder
- Capsular stabilization .
- Bankart repair l
- Anterior shoulder instability -
- SLAP lesion repairs -
- । Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs .
- Deltoid repairs .
- . Rotator cuff tear repairs
- . Biceps tenodesis
Foot and Ankle
- Hallux valgus repairs .
- Medial or lateral instability repairs/reconstructions .
- Achilles tendon repairs/reconstructions .
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstructions
- Bunionectomy
- Flexor Hullucis Longus (FLH)
- Tendon Transfers
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2/3 KO83675 > (Division Sign-OFF) Division of General, Restorative, and Neurological Devices
510(k) Numbe