(158 days)
P960054,P960047
Not Found
No
The summary describes a mechanical implant component for hip replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a component of a total hip prosthesis, which is used to treat hip dislocation and instability, thus providing a therapeutic benefit by addressing a medical condition.
No
Explanation: This device is a component of a total hip prosthesis, used to treat hip dislocation. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly states it is a physical component (polyethylene liners with a locking ring) intended for surgical implantation as part of a total hip prosthesis.
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 device is a component of a total hip prosthesis used in surgical procedures on patients. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant designed to be placed within the body. IVDs are typically reagents, instruments, or systems used to examine specimens taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the Ringloc® Constrained Liner is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ringloc® Constrained Liners are indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.
Product codes
KWZ
Device Description
The Ringloc® Constrained Acetabular Liners are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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
Clinical Testing: This device was part of the Ringloc® Constrained Liner Clinical Study- IDE #G990138. Please refer to the clinical data in the annual progress report that was submitted to the FDA on March 8, 2002.
Key Metrics
Not Found
Predicate Device(s)
P960054, P960047
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
OCT 25 2002
BIOMET
KC2K-1
page 1 of 2
OCT 2 5 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley
Telephone: (219) 267-6639 |
| Proprietary Name: | Ringloc® Constrained Liner |
| Common Name: | Constrained Acetabular Insert |
Classification: Prosthesis, hip, constrained, metal/polymer (CFR 888.3310).
Device Classification: Class II
Legally Marketed Device to which Substantially Equivalence is Claimed: Johnson & Johnson S-ROM® Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047.
Device Description: The Ringloc® Constrained Acetabular Liners are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.
Indications for Use: The Ringloc® Constrained Liners are indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.
Summary of Technologies: The Ringloc® Constrained Liner-the materials, design, sizing, and indications are similar or identical to the predicate devices.
Non-Clinical Testing: Mechanical testing, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liner presented no new risks and is, therefore, substantially equivalent to the predicate device.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
()[FFICE 574.267.6639
FAX 574.267.81.37
E-MAIL biomet@biomet.com
1
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Clinical Testing: This device was part of the Ringloc® Constrained Liner Clinical Study- IDE #G990138. Please refer to the clinical data in the annual progress report that was submitted to the FDA on March 8, 2002.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a symbol that resembles three stylized human figures or profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2002
Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K021661
Trade Name: RingLoc® Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: August 19, 2002 Received: August 20, 2002
Dear Ms. Binkley:
We have reviewed your Section 510(k) premarket 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) 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 mav 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.
3
Page 2 – Ms. Dalene T. Binkley
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
L. Mark McMillan
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):
DEVICE NAME: Ringloc® Constrained Liner
INDICATIONS FOR USE:
The Ringloc® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __
(Per 21 CFR 801.109)
OR
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Over-The-Counter-Use (Optional Format 1-2-96)