(232 days)
Not Found
No
The device description and intended use clearly describe a mechanical suture anchor and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is used to attach soft tissue to bone for various reconstructive and repair procedures, which are therapeutic interventions aimed at restoring function or correcting a physical problem.
No
Explanation: The device is described as a "suture anchoring device" used for attaching soft tissue to bone. Its intended uses are for surgical repairs and reconstructions. There is no mention of it being used to identify, detect, or monitor a medical condition, which are typical functions of a diagnostic device.
No
The device description explicitly states it is a "titanium suture anchoring device with an attached coated non-absorbable braided suture," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Bone Bullet Suture Anchor Function: The description clearly states that the Bone Bullet Suture Anchor is a device used to attach soft tissue to bone within the body during surgical procedures. It is a surgical implant, not a diagnostic test.
The information provided describes a surgical device used for repair and reconstruction, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Bone Bullet Suture Anchor is used to attach soft tissue to bone for the following indications:
- Foot and Ankle
-
- Hallux Valgus repairs
-
- Midfoot reconstructions
-
- Elbow, Wrist and Hand
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- PIP joint ligament reconstructions
-
- Profundus tendon reattachment
-
Product codes
HWC, MBI
Device Description
The Bone Bullet Suture Anchor is a titanium suture anchoring device with an attached coated non-absorbable braided suture size SP #2-0 used to attach soft tissue to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot and Ankle, Elbow, Wrist and Hand
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)
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
NOV 1 6 1999
September 15, 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 Bone Bullet Suture Anchor, 510(k) Number K991024.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Laura Seneff Manager, Regulatory Affairs
C. Device Name
| Trade Name: | Bone Bullet Suture Anchor |
|---|---|
| Common Name : | Suture Anchor |
| Classification Names : | Smooth or threaded |
| metallic bone fixation | |
| fastener 21 CFR 888.3040 | |
| Proposed Class/Device : | |
| Product Code | Class II-78 MBI |
D. Predicate/Legally Marketed Devices
Mini-Revo Soft Tissue Anchor Linvatec Corporation
UltraFix MicroMite Li Medical
1
Summary of Safety and Effectiveness Bone Bullet Suture Anchor 510(k) #K991024 September 15, 1999 Page 2 of 3
Device Description ய்
The Bone Bullet Suture Anchor is a titanium suture anchoring device with an attached coated non-absorbable braided suture size SP #2-0 used to attach soft tissue to bone.
r. Intended Use
This device is used to attach soft tissue to bone for the following indications:
Foot and Ankle
-
- Hallux Valgus repairs
-
- Midfoot reconstructions
Elbow, Wrist and Hand
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- PIP joint ligament reconstructions
-
- Profundus tendon reattachment
G. Substantial Equivalence
The Bone Bullet Suture Anchor is substantially equivalent in function and intended use to the Mini-Revo Suture Anchor (Linvatec Corporation) and UltraFix MicroMite (Li Medical).
The similarities/dissimilarities to the predicate are shown in the attached table.
2
Summary of Safety and Effectiveness Bone Bullet Suture Anchor 510(k) #K991024 September 15, 1999 Page 3 of 3
CHART OF SIMILARITIES AND DISSIMILARITIES
| Company | Device Name | Intended Use | Material | Single-Use
Reusable | Method of
Sterilization | Design |
|---------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------|----------------|------------------------|----------------------------|---------------------------------------------------------------------|
| NEW PRODUCT
Linvatec Corp. | Bone Bullet | Soft tissue to bone fixation for foot,
ankle, elbow, wrist and hand surgical
procedures. | Titanium Alloy | Sterile
Single-use | Gamma
Radiation | Length 4.57mm
Diameter 1.3mm |
| PREDICATE
Linvatec Corp.
510(k)#
K953954 | Mini-Revo Suture
Anchor | Soft tissue to bone fixation for
shoulder, knee, foot, ankle, elbow,
wrist and hand surgical procedures. | Titanium Alloy | Sterile
Single-use | Gamma
Radiation | Length 8.89mm
Diameter:
2.8mm (Major)
1.6mm (Minor) |
| PREDICATE
Li Medical
510(k)#
K981764 | UltraFix MicroMite | Soft tissue to bone fixation for
shoulder, wrist, elbow, knee, foot and
ankle surgical procedures. | Titanium Alloy | Sterile
Single-use | Gamma
Radiation | Length 3.7mm
Diameter:
1.3mm (undeployed)
2.7mm (deployed) |
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Ms. Laura Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
K991024 Re: Bone Bullet™ Suture Anchor Trade Name: Regulatory Class: II Product Codes: HWC and MBI September 16, 1999 Dated: September 20, 1999 Received:
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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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. ਜ 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 requlation 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 requlations.
4
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 qener 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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
September 15, 1999
.. ...........................................................................................................................................................................
Page 1 of 1
510(k) Number K991024
Device Name: Bone Bullet™ Suture Anchor
Indications for Use:
The Bone Bullet Suture Anchor is used to attach soft tissue to bone for the following indications:
Foot and Ankle
-
- Hallux Valgus repairs
- 2 . Midfoot reconstructions
Elbow, Wrist and Hand
- 1 . Scapholunate ligament reconstructions
- 2 . Ulnar or radial collateral ligament reconstructions
-
- PIP joint ligament reconstructions
- 4 . Profundus tendon reattachment
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-296)
(Division Sign-Off)