(154 days)
Not Found
K950202, #G990138
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a component of a total hip prosthesis used to prevent dislocations, indicating a structural and mechanical function rather than a direct therapeutic one.
No
The device, Ringloc® Constrained Liners II, is a component of a total hip prosthesis used in patients at high risk of dislocation. Its function is to capture the modular head within the prosthesis, and it is primarily described as a physical component for surgical implantation, not a tool for diagnosing medical conditions.
No
The device description clearly indicates it is a physical medical device (polyethylene liners with a locking ring) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a component of a total hip prosthesis used in surgical procedures to address hip instability and dislocation. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implantable component (polyethylene liner with a locking ring) designed to be surgically placed within the hip joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used to mechanically stabilize a joint.
N/A
Intended Use / Indications for Use
The Ringloc® Constrained Liners II 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 (comma separated list FDA assigned to the subject device)
KWZ
Device Description
The Ringloc® Constrained Acetabular Liners II are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.
The Ringloc® Constrained Liners II are the next generation in Biomet's constrained liner series. These constrained liners have been modified when compared to the Ringloc® Constrained Liners that were cleared in 510(k) K950202 and are now currently in IDE #G990138. The modifications made to the new devices include a thicker locking ring, increase in polyethylene around the ring groove on the liner, and a thicker polyethylene bummer on the liner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liners II presented no new risks and are, therefore, substantially equivalent to the predicate device.
Clinical Testing: The device in this 510(k) premarket notification is a modification of the device that was part of an approved IDE study for the Ringloc® Constrained Liner-#G990138.
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.
Not Found
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.
K950202, #G990138
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
§ 888.3310 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
BIOMET
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 II |
| 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 II are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.
The Ringloc® Constrained Liners II are the next generation in Biomet's constrained liner series. These constrained liners have been modified when compared to the Ringloc® Constrained Liners that were cleared in 510(k) K950202 and are now currently in IDE #G990138. The modifications made to the new devices include a thicker locking ring, increase in polyethylene around the ring groove on the liner, and a thicker polyethylene bummer on the liner.
Indications for Use: The Ringloc® Constrained Liners II 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.
MAHING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - - -
.
SHIPPING ADDRESS 56 E. Bell Drive
Warsaw, IN 46582
.
()FFICE 574.267.66.39 FAX 574.267.8137
E-MAIL biomet@biomet.com
1
Summary of Technologies: The Ringloc® Constrained Liners II-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 Liners II presented no new risks and are, therefore, substantially equivalent to the predicate device.
Clinical Testing: The device in this 510(k) premarket notification is a modification of the device that was part of an approved IDE study for the Ringloc® Constrained Liner-#G990138.
02/728
page 2 of 2
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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administratio 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: K021728
Trade Name: RingLoc® Constrained Liner II 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 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.
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,
b. Mark N. Mellaun
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
Page
510 (k) NUMBER (IF KNOWN):
DEVICE NAME: Ringloc® Constrained Liners II
INDICATIONS FOR USE:
The Ringloc® Constrained Liner is indicated for use as 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
510(k) Number -
Over-The-Counter-Use (Optional Format 1-2-96)