(234 days)
Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components 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.
Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Biolox® delfa Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper. This submission covers 28mm diameter heads with neck lengths of -3, 0, +3 and +5 and 32mm diameter heads with neck lengths of -3, 0, +3 and +6.
The Biomet Biolox® delta Ceramic Heads device is a modular ceramic head intended for use in total hip replacement. The provided documentation does not include any clinical or standalone performance studies against a set of acceptance criteria. Instead, the submission relies solely on non-clinical testing to demonstrate substantial equivalence to predicate devices.
Here's a breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was performed or reported, a table of acceptance criteria and reported device performance related to diagnostic accuracy, sensitivity, specificity, or similar metrics (which are typical for AI-powered devices) cannot be created from the provided text.
The closest information provided is about meeting non-clinical testing parameters:
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| All parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met | All parameters were met. |
This indicates that the device met the established engineering and materials performance standards for ceramic hip systems, likely related to strength, wear, biocompatibility, etc.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No clinical test set or data from human subjects was used for this 510(k) submission. The testing was entirely non-clinical (laboratory/mechanical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No clinical test set requiring expert ground truth establishment was conducted. The ground truth for the non-clinical testing would be derived from established engineering standards and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set requiring adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. No MRMC study was done, as this is a physical medical device (ceramic hip head), not an AI-powered diagnostic tool. The submission states, "Clinical Testing: None provided."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical implantable device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical testing, the "ground truth" would be the established performance specifications and material properties defined in the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems." This would involve physical measurements and tests conforming to recognized standards (e.g., ISO standards for implants).
8. The sample size for the training set:
Not applicable. There was no "training set" in the context of machine learning or AI algorithms, as this is a physical device.
9. How the ground truth for the training set was established:
Not applicable, as there was no training set.
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MAR 2 5 2005
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Biolox® delta Ceramic Heads
Common or Usual Name: Ceramic Modular Head
Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Zirconia Ceramic Modular Heads cleared through 510(k) K943586, K925345 and K905687 and DePuy Ceramic Femoral Heads cleared through K031803.
Device Description: Biolox® delfa Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper. This submission covers 28mm diameter heads with neck lengths of -3, 0, +3 and +5 and 32mm diameter heads with neck lengths of -3, 0, +3 and +6.
Indications For Use: Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components 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.
Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.
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510(k) Summary Biolox® delta Ceramic Heads Biomet Manufacturing Corp. Page 2
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Summary of Technologies: The Biolox® delta Ceramic Heads are technologically similar to the predicate devices.
Non-Clinical Testing: All parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met for the devices contained in this 510(k).
Clinical Testing: None provided
Biolox is a trademark of Feldmuhle Anlager und Produktions – GHBH Corporation.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2005
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K042091
Trade/Device Name: Biolox® delta Ceramic Heads Regulation Numbers: 21 CFR 888.3353 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO
Dated: January 27, 2005 Received: January 28, 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 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.
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Page 2 – Ms. Patricia Sandborn Beres
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,
Hypt Rhodes
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042091
Device Name: Biolox® delta Ceramic Heads
Indications For Use: Biolox® delta Ceramic Heads are indicated for use in total hip Indications For Use. Diolox® ucila Ochamio Houds and acetabular components in cases of:
- cases of.
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Correction of nunclional deferrilly
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the Treatherit of non-anion, formoral rout, unmanageable by other techniques.
Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for Salvage/Oncology Hip and Total Fornal of online and revision of unsuccessful
cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful Cases of ligament actions) (K974558, K002757, K021380, K033871)
Interlocking hip stems are indicated for non-cemented application in cases of revision, Intentically mp stems are indications where severe proximal bone loss may trauma, tracture, onology of Sthility of a standard type hip replacement prosthesis. (K990830, K042774)
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)
concurrence of OBM, D.M.D.
Page 1 of 1
510(k) Number K04
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.