(29 days)
Not Found
No
The document describes a traditional hip replacement system with no mention of AI or ML in its intended use, device description, or performance studies.
Yes
This device is a total hip replacement component, which is used to treat various hip conditions, clearly indicating its therapeutic purpose.
No.
The document describes a total hip replacement system, which is a prosthetic device used for orthopedic surgery, not for diagnosing medical conditions.
No
The device description explicitly states that the devices are metallic, hemispherical, modular acetabular shell components with porous Ti-6Al-4V applied to the exterior. This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, 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 description clearly states the device is a "metallic, hemispherical, modular acetabular shell component" used in hip replacement surgery. This is an implantable surgical device, not a device used for testing biological samples.
- Intended Use: The intended use describes the conditions for which the hip replacement is indicated, all of which relate to structural issues with the hip joint requiring surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 falled.
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, bone loss, foint or soft tissue laxity, neuromuscular disease, or intra-operative instablify and for whom all other options to constrained acetabular components have been considered.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, JDG, KWZ, LWJ, LZO, MAY, MBL, MEH
Device Description
All devices are metallic, hemispherical, modular acetabular shell components. All shells have Regenerex™ (porous Ti-6Al-4V) applied to the exterior fixation surface. Each shell utilizes a modular polyethylene liner and a modular femoral head component that is a taper fit onto a femoral stem intra-operatively.
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)
Non-Clinical Testing: Device speditc risk analysis resulted in performance of design verification bench tests and validation activities. The results of design verification and validation activities do not raise new issues of safety and effectiveness.
Clinical Testing: None provided.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
K070369
BIOMET
510(k) Summary
Preparation Date: March 7, 2007
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Robert Friddle, Requlatory Affairs Specialist
Proprietary Name: Regenerex™ RingLoc® + Modular Acetabular Shell
Common Name: Acetabular component for a total hip replacement
Classification Code(s)/Name(s): Class II
Product Classification Codes, Names and Regulation numbers:
-
- JDG, prosthesis, hip, femoral component, cemented, metal 21 CFR 888.3360
-
- JDI, prosthesis, hip, semi-constrained, metal/polymer, cemented 21 CFR 888.3350
-
- KWZ, prosthesis, hip, constrained, cemented or uncemented, metal/polymer 21 CFR 888.3310
-
- LPH, prosthesis, hip, semi-constralned, metal/polymer, porous Uncemented 21 CFR 888.3358
-
- LWJ, prosthesis, hip, semi-constrained, metal/polymer, Uncemented 21 CFR 888.3360
-
- LZO, prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, Uncemented 21 CFR 888.3353
-
- MAY, prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous cemented, osteophilic finish 21 CFR 888.3353
-
- MBL, prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous 21 CFR 888.3358
-
- MEH, prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate 21 CFR 888.3353
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Porous Coated Acetabular Components, 510(k) K050124, deared October 4, 2005
Device Description: All devices are metallic, hemispherical, modular acetabular shell components. All shells have Regenerex™ (porous Ti-6Al-4V) applied to the exterior fixation surface. Each shell utilizes a modular polyethylene liner and a modular femoral head component that is a taper fit onto a femoral stem intra-operatively.
Image /page/0/Figure/20 description: The image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46682. The office number is 574.267.66.39, the fax number is 574.267.8137, and the email address is biomet@biomet.com.
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MAR 0 9 2007
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Biomet Manufacturing Corp. Regenerex Modular Acetabular Shell Page 2 of 2
Intended 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 falled.
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, bone loss, foint or soft tissue laxity, neuromuscular disease, or intra-operative instablify and for whom all other options to constrained acetabular components have been considered.
Summary of Technologies: The devices covered by this 510(k) are geometrically similar or identical to the predicate.
Non-Clinical Testing: Device speditc risk analysis resulted in performance of design verification bench tests and validation activities. The results of design verification and validation activities do not raise new issues of safety and effectiveness.
Clinical Testing: None provided.
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Image /page/2/Picture/1 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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 9 2007
Biomet Manufacturing Corp. c/o Mr. Robert Friddle Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K070369
Trade/Device Name: Regenerex™ RingLoc® + Modular Acetabular Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI, JDG, KWZ, LWJ, LZO, MAY, MBL, MEH Dated: January 29, 2007 Received: February 8, 2007
Dear Mr. Friddle:
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
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Page 2 - Mr. Robert Friddle
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millerson
Mark N. Melkerson Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Regenerex™ RingLoc® + Modular Acetabular Shell
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.
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, 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.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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 M. Millman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070369
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