(192 days)
Not Found
No
The device description and intended use focus on a physical, bioabsorbable suture anchoring device made of PLLA. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is described as a "bioabsorbable device used for soft tissue to bone fixation in orthopedic applications," which includes repairing injuries and reconstructing tissues. These actions fall under the definition of a therapeutic device, as they are intended to treat or alleviate a medical condition.
No
This device, the Bio-Anchor, is described as a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications. Its function is to anchor sutures for repairs and reconstructions, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly describes a physical, bioabsorbable implant made of PLLA, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications. This is a surgical device used directly on a patient's body during a procedure.
- Device Description: The description details a physical implantable device made of PLLA, designed to anchor suture for tissue repair.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.
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
Elbow, Wrist and Hand
- Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair
- Biceps tendon reattachment
Knee
- Extra-capsular repairs and reattachments of:
- medial collateral ligament
- lateral collateral ligament
- posterior oblique ligament or joint capsule to tibia
- joint capsule closure to anterior proximal tibia
- Extracapsular reconstruction, iliotibial band tenodesis
- Patellar realignment and tendon repairs
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.
The material used for this device is:
Anchor - Poly (L-lactic) acid (PLLA)
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 and Hand, Knee
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)
Not Found
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
§ 888.3030 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
Image /page/0/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three chevrons inside. The word "Linvatec" is in a bold, sans-serif font.
11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264
Carol A. Weideman, Ph.D.
Manager, Regulatory and Clinical Allairs
JUN - 9 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR.807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Bio-Anchor™ Absorbable Suture Anchor, 510(k) Number K964805.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
B. Company Contact
Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs
C. Device Name
Trade Name: Bio-Anchor Common Name: Suture Anchor Classification Name: Soft tissue to bone fixation device
D. Predicate/Legally Marketed Devices
Linvatec Preloaded Soft Tissue Anchor Linvatec Bio-Anchor
Image /page/0/Picture/16 description: The image shows the logo for A Bristol-Myers Squibb Company. The logo consists of a geometric design on the left and the company name on the right. The geometric design is a hexagon made up of smaller triangles. The company name is written in a serif font.
1
Summary of Safety and Effectiveness Bio-Anchor Absorbable Suture Anchor 510(k) # K964806 Page 2
E. Device Description
The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.
The material used for this device is:
Anchor - Poly (L-lactic) acid (PLLA)
. Intended Use
The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.
The Bio-Anchor Absorbable Suture Anchor is available in a 3.5mm size.
G. Substantial Equivalence
The Bio-Anchor Absorbable Suture Anchor is substantially equivalent in function and intended use to Linvatec's Preloaded Soft Tissue Anchor and Linvatec's Bio-Anchor. The material is identical to the original Linvatec Bio-Anchor.
The similarities/dissimilarities to the predicates are shown in the attached table.
2
Summary of Safety and Effectiveness Bio-Anchor Absorbable Suture Anchor 510(k) # K964805 Page 3
SUBSTANTIAL EQUIVALENCE INFORMATION:
CHART OF SIMILARITIES AND DISSIMILARITIES
| Company Name | Device Name | Intended Use | Material | Single-Use/
Reusable | Sizes |
|--------------------------------------------------------------------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------|------------------------------------------------------------|
| New Product:
Linvatec | Bio-Anchor | Soft tissue to
bone fixation in
orthopedic
applications
except for
anterior or
posterior cruciate
ligament repair or
reconstruction. | Poly (L-lactic)
acid | Single-Use
ETO
Sterilization | 3.5mm diameter
Suture:
USP Sizes #0 to #2 |
| Predicate:
Linvatec:
Preloaded Soft Tissue
Anchor
510(k) # K953954 | Preloaded Soft
Tissue Anchor | Soft tissue to
bone fixation | Titanium Alloy
Suture: Non-
absorbable
Braided Polyester | Single-Use
Gamma
Sterilization | 2.5mm - 5.2mm
diameter
Suture:
USP sizes #0 to #2 |
| Predicate:
Linvatec:
Bio-Anchor Absorbable
Suture Anchor
510(k) #K955486 | Bio-Anchor | Soft tissue to
bone fixation | Poly (L-lactic)
acid
#0, #1, or #2
Non-Absorbable
Suture | Single-Use
ETO
Sterilization | 3.5mm diameter
Suture:
USP Sizes #0 to #2 |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 1997
Carol A. Weideman, Ph.D. Manager, Requlatory and Clinical Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 34643
K964805 Re : Bio-Anchor® Absorbable Suture Anchor Requlatory Class: II Product Code: MAI Dated: March 20, 1997 March 21, 1997 Received:
Dear Dr. Weideman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Paqe 2 - Carol A. Weideman, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three white arrows pointing towards the center. The word "Linvatec" is written in a bold, sans-serif font.
11311 Concept Boulevard Largo, Florida
June 3, 1997
Page 1 of 2
510(k) Number (if known): K964805
Device Name: BIO-ANCHOR™ ABSORBABLE SUTURE ANCHOR
Indications for Use:
The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in THE Blo Anonor is a bloaders anterior or posterior cruciate ligament repair or reconstruction.
Shoulder_
- Bankart lesion repairs 1.
- SLAP lesion repairs 2.
- Acromio-clavicular separation repairs 3.
- Rotator cuff tear repairs 4.
- Capsular shift or capsulolabral reconstructions 5.
- Biceps tenodesis ୍.
- Deltoid repairs 7.
Foot and Ankle
- Hallux Valgus repairs 1 .
- Medial or lateral instability repairs/reconstructions 2.
- Achilles tendon repairs/reconstructions 3.
- Midfoot reconstructions 4.
Elbow, Wrist and Hand
- Scapholunate ligament reconstructions 1.
- Ulnar or radial collateral ligament reconstructions 2.
- Tennis elbow repair 3.
- Biceps tendon reattachment 4.
Use
2.801.109)
Prescription Use . (Per 21 CFR 801.109)
s
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number Y964805
6
K964805 Bio-Anchor™ Absorbable Suture Anchor Indications for Use June 3, 1997 Page 2 of 2
Knee
- Extra-capsular repairs and reattachments of: 1.
- medial collateral ligament a.
- lateral collateral ligament b.
- posterior oblique ligament or joint capsule to tibia « С.
- joint capsule closure to anterior proximal tibia d.
- Extracapsular reconstruction, iliotibial band tenodesis 2.
- Patellar realignment and tendon repairs 3.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K964805 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)