(89 days)
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No
The device description and intended use clearly describe a physical suture anchor and its applications, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a suture anchor used for reattaching soft tissue to bone, which is a therapeutic intervention aimed at restoring function and repairing damaged tissues.
No.
The device is a suture anchor intended for reattaching soft tissue to bone, which is a surgical repair function, not a diagnostic one.
No
The device description clearly states it is a physical suture anchor made from PEEK and stainless steel, preloaded with suture. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor clearly indicate it is a surgical implant used to reattach soft tissue to bone within the body. It is a physical device used in a surgical procedure, not for analyzing biological samples outside the body.
The information provided about the device's materials, intended surgical procedures, and performance testing (insertion, pull out, suture slide) all align with a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications;
Hip
Hip capsule repair - Acetabular labrum reattachment
Shoulder
Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
Knee
Extra-capsular repairs:
- Medial collateral ligament - Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs - Vastus medialis obliquous advancement
Iliotibial band 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
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is nonabsorbable 2.3 mm suture anchor manufactured from PEEK and comes preloaded with non-absorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand, Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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