(254 days)
Not Found
No
The device description and intended use are purely mechanical, describing a physical screw anchor for soft tissue reattachment. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is a screw anchor used to attach soft tissue to bone during healing, and its intended use is for various soft tissue reattachment procedures. It is a surgical implant designed to facilitate the healing process rather than directly providing therapy.
No
Explanation: The device is described as a screw anchor used for reattaching soft tissue to bone during healing, and its indications for use are surgical repair procedures. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description clearly states it is a physical screw anchor made of a specific material (85% L-Lactide/15% Glycolide) and available in different sizes, indicating it is a 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 surgical implant used for soft tissue reattachment to bone. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device is a physical screw anchor made of a resorbable material, designed to be implanted into bone.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical testing and comparison to predicate devices, which is typical for surgical implants, not IVDs.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical tool and implant used to repair injuries.
N/A
Intended Use / Indications for Use
Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/ tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MAI
Device Description
This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The device consists of a screw portion and a head portion. The screw portion engages the bone while the head portion provides a means to drive the anchor in and a means to attach the suture to the anchor. These anchors are comprised of 85% L-Lactide/15% Glycolide and are available in 3.5 mm and 5.5 mm diameter sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, wrist/hand, ankle/foot, elbow, and 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)
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to 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.
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
JUN 3 0 2004
BIOMET
510(k) Summary
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Mary L.Verstynen Contact Person: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Telephone: (574) 267-6639 extension 1343 Fax: (574) 372-1683
Proprietary Name: LactoScrew™ Screw Anchor
resorbable screw anchor Common Name:
Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Resorbable Screw Anchor, K012872
Device Description:
This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The device consists of a screw portion and a head portion. The screw portion engages the bone while the head portion provides a means to drive the anchor in and a means to attach the suture to the anchor. These anchors are comprised of 85% L-Lactide/15% Glycolide and are available in 3.5 mm and 5.5 mm diameter sizes.
Intended Use:
Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/
Image /page/0/Figure/18 description: The image shows contact information for a company, including mailing and shipping addresses. The mailing address is P.O. Box 587, Warsaw, IN 46581-0587, while the shipping address is 56 E. Bell Drive, Warsaw, IN 46582. The office phone number is 574.267.6639, the fax number is 574.267.8157, and the email address is biomet@biomet.com.
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Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, illotibial band tendodesis, and patellar ligament/ tendon repair.
Summary of Technologies: The LactoScrew™ Screw Anchors technological Characteristics (material and design) are similar to the predicate devices.
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes. The logo is black and white and appears to be a scanned or low-resolution image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2004
Ms. Mary L. Verstynen Biomet Orthopedics Incorporated 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581-0587
Re: K033355
Trade Name: LactoScrew™ Screw Anchor Regulation Number: 888.3040 Regulation Name: Smooth or metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: April 5, 2004 Received: April 6, 2004
Dear Ms. Verstynen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Mary L. Verstynen
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K033355
Device Name: LactoScrew™ Screw Anchor
Indications For Use:
Indications for the LactoScrew™ Screw Anchor include use in soft tissue reatiachment mulcations for the Edotoodrow - Bere, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff Singduder. Dalikal repair, och "Totleh repair, and one struction, biceps tendodesis, deltoid repair.
Prepair, capsule repair or capsulolabral reconstruction, biceps linemat repair, capsule repair of ouplaint reconstruction, ulnar/radial collateral ligament reconstruction.
reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. repairneconstruction, hallax valgus roomaticallateral ligament reconstruction, biceps tendon reconstruction.
tendon reconstruction.
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/ tendon repair.
(Please do not write below this line - continue on another Page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Miriam C. Provost | |
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices |
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
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