(84 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor device and its intended uses for soft tissue fixation. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is purely mechanical.
Yes.
This device is used for the fixation and reattachment of surgical suture material and soft tissue to bone for various repairs and reconstructions, which are therapeutic interventions.
No
This device is a surgical implant designed for the fixation of sutures and reattachment of soft tissue to bone. Its intended uses are therapeutic (repairing injuries) rather than diagnostic (identifying diseases or conditions).
No
The device description explicitly states it is a physical suture anchor made of non-absorbable materials, provided sterile, and preassembled onto an inserter. It also mentions being packaged with a guide and awl in some configurations. This clearly indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications for use clearly describe the device as being used for the fixation of nonabsorbable synthetic sutures and the reattachment of soft tissue to bone in various anatomical locations (shoulder, foot and ankle, elbow, wrist, hand, knee, pelvis, hip). These are all surgical procedures performed in vivo (within the living body).
- Device Description: The device is described as "Non-Absorbable Suture Anchors" provided sterile for single use and preassembled onto an inserter. This description aligns with a surgical implant or device used during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical and structural within the body.
IVD devices are specifically designed to be used in vitro (outside the living body) for diagnostic purposes. This device is clearly intended for surgical use in vivo.
N/A
Intended Use / Indications for Use
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of nonabsorbable synthetic sutures.
The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
-
- Acromio-clavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux Valgus repairs
-
- Medial or lateral instability repairs
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- Tennis elbow repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
The OBL Preloaded Series Anchor is intended for use only for the fixation of non-absorbable synthetic suture material for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
-
- Acromio-clavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux Valgus repairs
-
- Medial or lateral instability repairs/reconstructions
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- Lateral epicondylitis repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs:
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
Pelvis:
- 2. Bladder neck suspension procedures
- This indication is marketed separately from the orthopedic indications under the trade name Cinch®
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, wrist, and hand. Examples of such procedures include:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular sepairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.
Foot and Ankle:
Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.
Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular 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
Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
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
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs
Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee: Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs:
- Vastus medialis obliquous advancement
Hip:
Abductor tendon repair
The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip: Hip capsular repair -Acetabular labral repair
Shoulder: Capsular Stabilization - Bankart Repair -Anterior Shoulder Instability Repair -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 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 lliotibial band tenodesis
The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair
- Acetabular labrum . reattachment/reconstruction
Shoulder Capsular stabilization
- Bankart repair .
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff 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
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
The Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Bankart lesion repairs 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/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
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
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Hip:
Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
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
Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
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
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
Smith & Nephew Non-Absorbable Suture Anchors are provided in various non-absorbable materials. All of the Smith & Nephew Non-Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a quide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist, Hand, Knee, Pelvis, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices.
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.
K972326, K000797, K023021, K072785, K102660, K112526, K113274, K113294, K121018
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2015
Smith & Nephew, Incorporated Katherine Marcaccio Regulatory Affairs Specialist II 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K152566
Trade/Device Name: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra PK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 9, 2015 Received: September 10, 2015
Dear Katherine Marcaccio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 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 Act (Act) that 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 manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any 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); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152566
Device Name PEBA Anchor/Suture Combination
Indications for Use (Describe)
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of nonabsorbable synthetic sutures.
The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
-
- Acromio-clavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux Valgus repairs
-
- Medial or lateral instability repairs
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- Tennis elbow repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 EF
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152566
Device Name
2.0mm Mini-Tac Anchor, Model 10-1629-01
Indications for Use (Describe)
The OBL Preloaded Series Anchor is intended for use only for the fixation of non-absorbable synthetic suture material for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
-
- Acromio-clavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux Valgus repairs
-
- Medial or lateral instability repairs/reconstructions
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- Lateral epicondylitis repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs:
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
*Pelvis:
-
- Bladder neck suspension procedures
-
- This indication is marketed separately from the orthopedic indications under the trade name Cinch®
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
Indications for Use
510(k) Number (if known) K152566
Device Name Modification to Twinfix Ti Quick T
Indications for Use (Describe)
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, wrist, and hand. Examples of such procedures include:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular sepairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.
Foot and Ankle:
Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.
Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
Indications for Use
510(k) Number (if known) K152566
Device Name Twinfix FT PK
Indications for Use (Describe) The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular 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
Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
9
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
10
Indications for Use
510(k) Number (if known) K152566
Device Name
Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors
Indications for Use (Describe)
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs
Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee: Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement
Hip:
Abductor tendon repair
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
11
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
12
Indications for Use
510(k) Number (if known) K152566
Device Name FOOTPRINT Ultra PK Suture Anchors
Indications for Use (Describe) The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip: Hip capsular repair -Acetabular labral repair
Shoulder: Capsular Stabilization - Bankart Repair -Anterior Shoulder Instability Repair -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 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 lliotibial band tenodesis
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
13
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
14
Indications for Use
510(k) Number (if known)
K152566
Device Name
BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor
Indications for Use (Describe)
The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair
· Acetabular labrum reattachment/reconstruction
Shoulder Capsular stabilization · Bankart repair · Anterior shoulder instability
· SLAP lesion repairs
· Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff 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 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
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
15
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
16
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K152566
Device Name
HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor)
Indications for Use (Describe)
The Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Bankart lesion repairs 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/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
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
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Hip:
Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
17
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
18
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Bioraptor Curved 2.3 PK Suture Anchors
Indications for Use (Describe) The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
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
Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
19
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
20
Advanced Surgical Devices Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
T 978 749 1000 F 978 749 1599 www.smith-nephew.com
Image /page/20/Picture/3 description: The image contains the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The text is in a combination of gray and orange, with "smith&nephew" in orange.
510(k) Summary 2015
Date Prepared: November 9,
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | |
| 150 Minuteman Road | |
| Andover, MA 01810 | Katherine Marcaccio |
| Regulatory Affairs Specialist II | |
| Phone: (508) 261-3602 | |
| Fax: (978) 749-1443 |
| Device Name (Unmodified) | |
|---|---|
| Trade or proprietary name | Smith & Nephew Non-Absorbable Suture Anchors |
| Common or usual name | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification name | 21 CFR §888.3040 – Smooth or threaded metallic bone |
| fixation fastener |
Legally Marketed Predicate Device
The Smith & Nephew Non-Absorbable Suture Anchors are substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
| 510(k)
Number | Device Name | Clearance
Date |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K972326 | PEBA ANCHOR/SUTURE COMBINATION | 02/06/1998 |
| K000797 | 2.0mm MINI-TAC ANCHOR, MODEL 10-1629-01 | 04/03/2000 |
| K023021 | MODIFICATION TO SMITH & NEPHEW TWINFIX TI
QUICK-T | 10/04/2002 |
| K072785 | Twinfix FT PK | 12/10/2007 |
| K102660 | BIORAPTOR CURVED 2.3 PK Suture Anchors | 12/13/2010 |
| K112526 | TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX
ULTRA HA Suture Anchors | 01/31/2012 |
| K113274 | FOOTPRINT Ultra PK suture anchors | 03/06/2012 |
| K113294 | SMITH & NEPHEW Healicoil PK Suture Anchor | 01/20/2012 |
| K121018 | Smith & Nephew, Inc. BIORAPTOR 2.9 Suture Anchor,
BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR
Suture Anchor, BIORAPTOR Knotless Suture Anchor | 06/22/2012 |
21
Image /page/21/Picture/1 description: The image shows the logo for Smith & Nephew. The logo features an orange flower-like symbol on the left. To the right of the symbol, the text "We are smith&nephew" is displayed, with "We are" in gray and "smith&nephew" in orange.
Smith & Nephew Non-Absorbable Suture Anchors are provided in various non-absorbable materials. All of the Smith & Nephew Non-Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a quide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.
Intended Use
Smith & Nephew Suture Anchors - PEBA Anchor/Suture Combination This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.
The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
-
- Acromio-clavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral
- reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux Valgus repairs
-
- Medial or lateral instability repairs
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon
- repairs/reconstructions
Elbow, Wrist, and Hand:
-
- Scapholunate ligament
- reconstructions
-
- Ulnar or radial collateral ligament
- reconstructions
-
- Tennis elbow repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis
- obliquous advancement
Smith & Nephew Suture Anchors – 2.0mm MINI-TAC ANCHOR, MODEL 10-1629-01 The OBL Preloaded Series Anchor is intended for use only for the fixation of non-
absorbable synthetic suture material for the following indications:
Shoulder:
22
-
- Bankart lesion repairs
-
- SLAP lesion repairs
-
- Acromio-clavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux Valgus repairs
-
- Medial or lateral instability repairs/reconstructions
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- Lateral epicondylitis repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs:
- a, medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
*Pelvis:
-
- Bladder neck suspension procedures
- This indication is marketed separately from the orthopedic indications under the trade name Cinch®
Smith & Nephew Suture Anchors – Modification to Twinfix Ti Quick T
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist, and hand. Examples of such procedures include:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.
Foot and Ankle:
23
Image /page/23/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
Hallux Valqus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.
Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
Smith & Nephew Suture Anchors – Twinfix FT PK
The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis
Foot and Ankle:
Hallux valgus repairs
Elbow:
Ulnar or radial collateral liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee:
Extra-capsular repairs:
- Medial collateral liqament -
- Lateral collateral ligament -
- Posterior oblique ligament -
Patellar realignment and tendon
24
Image /page/24/Picture/1 description: The image shows the logo for Smith & Nephew. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
repairs:
-Vastus medialis obliquous advancement Iliotibial band tenodesis
Smith & Nephew Suture Anchors - Bioraptor Curved 2.3 PK Suture Anchors The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
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
Foot and Ankle:
Hallux valgus repairs Medial or lateral instability
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
25
Image /page/25/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of that, the words "smith&nephew" are written in orange.
repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Smith & Nephew Suture Anchors - Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs
Foot and Ankle:
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Elbow:
Ulnar or radial collateral liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee:
Extra-capsular repairs:
- Medial collateral ligament ।
- Lateral collateral ligament ।
- Posterior oblique ligament -
Iliotibial band tenodesis Patellar realignment and tendon repairs:
- Vastus medialis obliquous advancement
Hip:
Abductor tendon repair
26
Image /page/26/Picture/1 description: The image contains the logo for Smith & Nephew. The logo features an orange flower-like symbol on the left. To the right of the symbol is the text "We are smith&nephew", with "We are" in gray and "smith&nephew" in orange.
Smith & Nephew Suture Anchors – FOOTPRINT Ultra PK Suture Anchors
The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon repair.
27
Image /page/27/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The text "We are" is in gray, while "smith&nephew" is in orange, matching the color of the flower symbol.
Smith & Nephew Suture Anchors - HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor)
The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs 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/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Knee:
Extra-capsular repairs:
- Medial collateral ligament ।
- Lateral collateral ligament i
- । Posterior oblique ligament
Patellar realignment and tendon repairs:
- Vastus medialis obliquous advancement Iliotibial band tenodesis
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Hip:
Gluteal tendon repairs
- -Gluteus medius and gluteus minimus repair
28
Image /page/28/Picture/1 description: The image contains the Smith & Nephew logo. The logo features an orange flower-like symbol on the left. To the right of the symbol, the text "We are smith&nephew" is displayed, with "We are" in gray and "smith&nephew" in orange.
Smith & Nephew Suture Anchors - BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor
The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair
- Acetabular labrum . reattachment/reconstruction
Shoulder
Capsular stabilization
- Bankart repair .
- Anterior shoulder instability ●
- SLAP lesion repairs ●
- Capsular shift or capsulolabral ● reconstructions
Acromioclavicular separation repairs Deltoid repairs Rotator Cuff 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
Technological Characteristics
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
29
Image /page/29/Picture/1 description: The image contains the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of that, the words "smith&nephew" are written in orange. The logo is simple and modern.
Smith & Nephew Non-Absorbable Suture Anchors are substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices in this submission and raises no new issues of safety and efficacy.
Summary of Performance Data
Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices.
Substantial Equivalence Information
The substantial equivalence of the Non-Absorbable Suture Anchors is based on identical indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the identical features to the predicates, the Non-Absorbable Suture Anchors are substantially equivalent to the predicates.