(71 days)
Not Found
No
The summary describes a mechanical implant and associated instruments for surgical fixation, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is an implantable medical device used for femoral fixation of soft tissue grafts during cruciate ligament reconstruction, which is a surgical procedure. While it aids in a therapeutic procedure, the device itself is not providing therapy.
No
The device is a surgical implant designed for femoral fixation of soft tissue grafts during cruciate ligament reconstruction, not for diagnosis.
No
The device description clearly states it consists of absorbable implants (crosspin and graft harness) and re-usable instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of implants (crosspin and graft harness) and instruments used in a surgical setting.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Pinn–ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.
Product codes
HTY
Device Description
The Linvatec Pinn-ACL® CrossPin consists of absorbable crosspin and graft harness implants made from poly L-lactic acid, high strength polyethylene fiber to be used with manual, re-useable instruments to facilitate the precise positioning of the implants (Crosspin refers to the both the crosspin and graft harness implants. The implants are single-use and sterile. The instruments are supplied non-sterile and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
K011172, K974341, K003077, K973758
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
K04-3106 pg143
JAN 1 9 2005
PROPRIETARY INFORMATION - LINVATEC CORPORATION
November 5, 2004
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 Traditional 510(k) Summary of Safety and Effectiveness for the Pinn -ACL CrossPin 510(k) Number _______________________________________________________________________________________________________________________________________________________
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Elizabeth M. Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
Pinn-ACL® CrossPin Trade Name:
Common Name: crosspin
Biodegradable, Soft Classification Names: Fastener, Fixation, Tissue, 21 CFR 888.3030
Proposed Class/Device: Class II
MAI Product Code:
1
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Summary of Safety and Effectiveness Pinn-ACL® Crosspin 510(k) # November 5, 2004
Predicate/Legally Marketed Devices D.
| Bio - Transfix
| Arthrex, Inc. | 510(k) # K011172 |
|---|---|
| Rigid Fix® | |
| Mitek | 510(k) # K974341 |
| Bionx SmartScrew ® | |
| Bionx | 510 (k) # 003077 |
| BioScrew® | |
| Linvatec Corporation | 510(k) # K973758 |
Device Description E.
consists of absorbable crosspin and graft The Linvatec Pinn-ACL® CrossPin harness implants made from poly L-lactic acid, high strength polyethylene fiber to be used with manual, re-useable instruments to facilitate the precise positioning of the implants (Crosspin refers to the both the crosspin and graft harness implants. The implants are single-use and sterile. The instruments are supplied non-sterile and must be sterilized prior to use.
F. Intended Use
The Pinn–ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.
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2
pge 3/2
PROPRIETARY INFORMATION - LINVATEC CORPORATION
Substantial Equivalence G.
The Pinn-ACL® CrossPin is substantially equivalent to in design and intended use and materials to the Bio – Transfix (510(k) # K011172) and Arthrex, Inc., RigidFix™ (510(k) # K974341).
The Pinn-ACL® CrossPin implant is identical to the materials in the SmartScrew® (510(k) # K003077) and the BioScrew @(510(k) # K097358).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" around the perimeter. Inside the circle is a stylized graphic of three horizontal lines that curve upwards, resembling a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2005
Ms. Elizabeth M. Paul Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Re: K043106
Trade/Device Name: Pinn-ACL® CrossPin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: November 5, 2004 Received: November 9, 2004
Dear Ms. Paul:
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.
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.
4
Page 2 - Ms. Elizabeth M. Paul
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 (240) 276-0120. 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 may be obtained 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/industry/support/index.html.
Sincerely yours.
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
5
PROPRIETARY INFORMATION - LINVATEC CORPORATION
November 5, 2004
510(k) Number (if known):
Device Name: Pinn --ACL® CrossPin
Indications for Use:
The Pinn – ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.
Prescription Use X_
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
5
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CD/RH, Office of Device/Evaluation (ODE)
Fence of onseptor Dette
Division Sign-6 Division of General, Restorative, and Neurological Devices
510(k) Number.