(258 days)
Not Found
No
The summary describes a standard hip replacement system with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a total hip replacement system, which is used to treat various conditions of the hip joint, indicating a therapeutic purpose.
No
The device is a total hip replacement system, which is a therapeutic device, not a diagnostic one. Its purpose is to replace a diseased or damaged hip joint, not to diagnose a medical condition.
No
The device description explicitly states that the devices are "metallic, full-hemisphere, acetabular shell components," which are physical hardware implants.
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.
- Device Description: The provided description clearly states that this device is a "metallic, full-hemisphere, acetabular shell component" used in total hip replacement surgery. It is an implantable device used within the body, not for testing samples outside the body.
- Intended Use: The intended use describes surgical procedures for treating various hip conditions, which is a therapeutic intervention, not a diagnostic test.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cemented or non-cemented total hip replacement in case of
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision procedures where other treatment or devices have failed.
M2a™ Ring-Loc liners are only cleared for use in non-cemented acetabular shells.
The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, 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, KWA, JDI, MAY, MEH, LPH
Device Description
All devices are metallic, full-hemisphere, acetabular shell components. Each shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature individuals
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): 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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K050124 page 1 of 2
OCT 4 - 2005
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist
Proprietary Name(s): Ranawat Burstein® Acetabular Components, Full Hemisphere Acetabular Components, Quadrant Sparing Shells, and McLaughlin™ +5 Acetabular System.
Common or Usual Name: Acetabular component for a total hip replacement
Classification Name:
-
- Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
-
- Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR 888.3330)
-
- Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350)
-
- Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)
-
- Hip joint metal/polmer/metal semi-constrained, porous-coated, uncemented prosthesis (21 C.F.R. 888.3358)
Device Product Code: KWZ, KWA, JDI, MAY, MEH, LPH
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The Logally mattained in this 510(k) submission are substantially equivalent to devices cleared through the following 510(k)s:
| Ranawat Burstein® Total Hip System | K921277 |
|---|---|
| Full Hemisphere Ring-Loc Liner | K920640 |
| Expanded Indications for Non-cemented Porous Coated Hips | K030055 |
Device Description: All devices are metallic, full-hemisphere, acetabular shell components. Each shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery.
1
510(k) Summary Porous Coated Acetabular Components Page 2
Intended Use: Cemented or non-cemented total hip replacement in case of
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision procedures where other treatment or devices have failed.
M2a™ Ring-Loc liners are only cleared for use in non-cemented acetabular shells.
The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, 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 devices to be covered by this 510(k) for are geometrically similar or identical to devices previously covered by 510(k).
Clinical and Non-Clinical Testing: None provided
All trademarks are property of Biomet, Inc. except for the following: Ranawat/Burstein is a trademark of the Hospital for Special Surgery
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
OCT 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K050124 Trade/Device Name: Porous Coated Acetabular Components Regulation Number: 21 CFR 888.3330 Regulations: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, KWZ, LPH, MAY, MEH, and JDI Dated: September 19, 2005 Received: September 20, 2005
Dear Ms. Beres:
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
3
Page 2 - Ms. Patricia Beres
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 (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 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,
Mark A. Millican
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
1050124 510(k) Number (if known):
Device Name: Porous Coated Acetabular Components
Indications For Use: Cemented or non-cemented total hip replacement in cases of
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision procedures where other treatment or devices have failed.
M2a™ Ring-Loc liners are only cleared for use in non-cemented acetabular shells.
The indications for use of the constrained liners compatible with this system are as follow:
- The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Prescription Use __X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millenson
4
(Division Sign-Off) (Division of General, Restorative, and Neurological De
Page 1 of 1
510(k) Number