LogoFDA 510(k) Search
K Number
K990770
Device Name
BIORC ANCHOR
Manufacturer
LINVATEC CORP.
Date Cleared
1999-07-30

(143 days)

Product Code
HWCMAI
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder (Bankart lesion repair, 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, Lateral and Medial Epicondylitis, Biceps tendon reattachment), Knee (Extracapsular 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), Bladder Neck Suspension (Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility).
Device Description
The BioRC Anchor is a cannulated, threaded, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly(L-lactide acid), which is used to attach soft tissue to bone. The device is preloaded on a disposable driver used to insert it into the bone.
More Information

K963932, K911837, K983186

Not Found

No
The device description and intended use are purely mechanical and material-based. There is no mention of any computational or analytical functions that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".

No.
The device is a bioabsorbable anchor used for surgical fixation of soft tissue to bone, which is a structural or supportive function, not a therapeutic (treating disease or illness) function.

No.
The device description and intended use clearly state that the BioRC Anchor is a fixation device used to attach soft tissue to bone, which is a therapeutic function, not a diagnostic one.

No

The device description explicitly states it is a "cannulated, threaded, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly(L-lactide acid)". This describes a physical, implantable hardware device, 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 device used to physically attach soft tissue to bone during surgical procedures. This is a therapeutic/surgical function, not a diagnostic one.
  • Device Description: The description details a physical implantable device made of bioabsorbable material, designed for mechanical fixation. This is consistent with a surgical implant, not a diagnostic reagent or instrument used to examine specimens from the human body.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis or monitoring of a disease or condition based on in vitro testing.

Therefore, the BioRC Anchor is a surgical implant/device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

Shoulder

    1. Bankart lesion repair
    1. SLAP lesion repairs
    1. Acromio-clavicular separation repairs
    1. Rotator cuff tear repairs
    1. Capsular shift or capsulolabral reconstructions
    1. Biceps tenodesis
    1. Deltoid repairs

Foot and Ankle

    1. Hallux Valgus repairs
    1. Medial or lateral instability repairs/reconstructions
    1. Achilles tendon repairs/reconstructions
    1. Midfoot reconstructions

Elbow, Wrist and Hand

    1. Scapholunate ligament reconstructions
    1. Ulnar or radial collateral ligament reconstructions
    1. Lateral and Medial Epicondylitis
    1. Biceps tendon reattachment

Knee

    1. Extracapsular repairs and reattachments of:
    • a. medial collateral ligament
    • b. lateral collateral ligament
    • c. posterior oblique ligament or joint capsule to tibia
    • d. joint capsule closure to anterior proximal tibia
    1. Extracapsular reconstruction, iliotibial band tenodesis
    1. Patellar realignment and tendon repairs

Bladder Neck Suspension

  1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Product codes

MAI, HWC

Device Description

The BioRC Anchor is a cannulated, threaded, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly(L-lactide acid), which is used to attach soft tissue to bone. The device is preloaded on a disposable driver used to insert it into the bone.

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, Bladder Neck

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)

Testing has been done to prove safety and effectiveness of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K963932, K911837, K983186

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

May 13, 1999

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 BioRC Anchor 510(k) Number K990770.

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Laura Seneff Manager, Regulatory Affairs

C. Device Name

Trade Name:: BioRC Anchor
Common Name: BioAbsorbable Soft Tissue Anchor
Classification Names: None Assigned

Proposed Class/Device : Class II-87 MAI, Fastener Product Code Fixation, Biodegradable, Soft Tissue

D. Predicate/Legally Marketed Devices

Revo Suture Anchor Linvatec Corporation

Suretac Acufex

Pre-loaded Bio-Anchor Linvatec Corporation

1

Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 Page 2 of 4

E. Device Description

The BioRC Anchor is a cannulated, threaded, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly(L-lactide acid), which is used to attach soft tissue to bone. The device is preloaded on a disposable driver used to insert it into the bone.

F. Intended Use

This device is used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

Shoulder

    1. Bankart lesion repair
    1. SLAP lesion repairs
    1. Acromio-clavicular separation repairs
    1. Rotator cuff tear repairs
    1. Capsular shift or capsulolabral reconstructions
    1. Biceps tenodesis
    1. Deltoid repairs

Foot and Ankle

    1. Hallux Valgus repairs
    1. Medial or lateral instability repairs/reconstructions
    1. Achilles tendon repairs/reconstructions
    1. Midfoot reconstructions

Elbow, Wrist and Hand

    1. Scapholunate ligament reconstructions
    1. Ulnar or radial collateral ligament reconstructions
    1. Lateral and Medial Epicondylitis
    1. Biceps tendon reattachment

2

Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 - -Page 3 of 4

Knee

    1. Extracapsular repairs and reattachments of:
    • a. medial collateral ligament
      • b. lateral collateral ligament
    • c. posterior oblique ligament or joint capsule to tibia
    • d. joint capsule closure to anterior proximal tibia
    1. Extracapsular reconstruction, iliotibial band tenodesis
    1. Patellar realignment and tendon repairs

Bladder Neck Suspension

  1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.

G. Substantial Equivalence

The BioRC Anchor is substantially equivalent in design and intended use to the Revo Suture Anchor (Linvatec Corporation) and SureTac (Acufex).

The BioRC Anchor is substantially equivalent in materials to the Preloaded Bio-Anchor Absorbable Suture Anchor (Linvatec Corporation).

Testing has been done to prove safety and effectiveness of the device.

The similarities/dissimilarities to the predicate are shown in the attached table.

3

Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 Page 4 of 4

.. .

CHART OF SIMILARITIES AND DISSIMILARITIES

| Company | Device Name | Intended Use | Material | Single-Use
Reusable | Method of
Sterilization | Design |
|------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| NEW
PRODUCT
Linvatec
Corp. | BioRC Anchor | Soft tissue to bone fixation for
shoulder, knee, foot, ankle,
elbow, wrist, hand and bladder
neck suspension procedures. | Poly(L-lactic acid) | Sterile
Single-use | Ethylene
Oxide | 6mm x 22mm
Threaded,
cannulated device
with a head to
attach soft tissue to
bone. |
| PREDICATE
Linvatec
Corp.
510(K)#
K963932 | Revo Suture
Anchor | Soft tissue to bone fixation for
shoulder, knee, foot, ankle,
elbow, wrist, hand and bladder
neck suspension procedures. | Titanium Alloy | Sterile
Single-use | Gamma Radiation | 2.5mm-5.2mm
length
Threaded device
that attaches soft
tissue to bone. |
| PREDICATE
Acufex
510(K)#
K911837 | Suretac | Soft tissue to bone fixation. | Polyglyconate | Sterile
Single-use | Ethylene Oxide | 8mm x 16mm
Cannulated tack
with ribs to hold the
device in the bone. |
| PREDICATE
Linvatec Corp
510(K)#
K983186 | Pre-loaded Bio-
Anchor | Soft tissue to bone fixation for
shoulder, knee, foot, ankle,
elbow, wrist, hand and bladder
neck suspension procedures. | Poly(L-lactic acid) | Sterile
Single-use | Ethylene Oxide | 3.5mm x 10.5mm
Ribbed device with
a loop at the
proximal end to
hold suture which
attaches the soft
tissue. |

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Ms. Laura Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

K990770 Re: Trade Name: BioRC Anchor Regulatory Class: II Product Code: MAI, HWC Dated: May 13, 1999 Received: May 14, 1999

Dear Ms. Seneff:

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 control provisions of the Act. The general control 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

5

Page 2 - Ms. Laura Seneff

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

6

May 13, 1999

Page 1 of 2

510(k) Number (if known): K990770

Device Name: BioRC Anchor

Indications for Use:

The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

Shoulder

    1. Bankart lesion repair
    1. SLAP lesion repairs
    1. Acromio-clavicular separation repairs
    1. Rotator cuff tear repairs
    1. Capsular shift or capsulolabral reconstructions
    1. Biceps tenodesis
    1. Deltoid repairs

Foot and Ankle

    1. Hallux Valgus repairs
    1. Medial or lateral instability repairs/reconstructions
    1. Achilles tendon repairs/reconstructions
    1. Midfoot reconstructions

Elbow, Wrist and Hand

    1. Scapholunate ligament reconstructions
    1. Ulnar or radial collateral ligament reconstructions
    1. Lateral and Medial Epicondylitis
    1. Biceps tendon reattachment

Knee

    1. Extracapsular repairs and reattachments of:
    • a. medial collateral ligament
    • b. lateral collateral ligament
    • c. posterior oblique ligament or joint capsule to tibia
    • d. joint capsule closure to anterior proximal tibia
    1. Extracapsular reconstruction, iliotibial band tenodeşis
    1. Patellar realignment and tendon repairs

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative DevicesK9907
510(k) Number

7

Indications for Use (con't):

Page 2 of 2

Bladder Neck Suspension

  1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use

Over-the-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

A. colles