(29 days)
The M2a-Magnum™ System is indicated for non-cemented use in patients requiring total hip replacement due to the following:
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic . variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
- . 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 of previously failed total hip arthroplasty
The M2a-Magnum™ ™ Tri-Spike™ Acetabular Components is a Co-Cr-Mo, full hemisphere shell in outer diameters of 44mm to 66mm designed for metal articulation. The outer surface of the shell features porous plasma spray coating for biological fixation and three dome spikes for rotational stability.
The provided document is a 510(k) summary for a medical device, the M2a-Magnum™ Tri-Spike™ Acetabular Component. This type of submission to the FDA is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a study with the details requested.
Therefore, the information you've asked for regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.
Here's why and what can be extracted:
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Acceptance Criteria and Reported Device Performance: This document states "Non-Clinical Testing: None provided" and "Clinical Testing: None provided." This indicates that the manufacturer did not submit specific performance metrics from a study to demonstrate the device meets acceptance criteria. Instead, the submission relies on the device's similarity to a previously approved (predicate) device. The "Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device" is the primary argument.
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Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Sample Size for Training Set, How Ground Truth for Training Set was Established: All of these points pertain to the details of a study (clinical or non-clinical performance evaluation), which, as stated above, were not provided in this 510(k) summary.
In summary, because no clinical or non-clinical testing was provided, the document does not contain the information required to fill out the table and answer the detailed questions about acceptance criteria and a study proving the device meets them. The 510(k) process in this case relies solely on demonstrating substantial equivalence to a previously marketed device (M2a-Magnum™ System, 510(k) K042037) based on design, materials, and processing methods being similar.
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510(k) Summarv
OCT 3 1 2006
| Preparation Date: | September 22, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Patricia Sandborn BeresSenior Regulatory Specialist |
| Proprietary Name: | M2a-Magnum™ Tri-SpikeTM Acetabular Component |
Common Name: Metal on metal acetabular component
Classification Code(s)/Name(s): 87 KWA - Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis (21 CFR 888.3330)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a-Magnum™ System, 510(k) K042037.
Device Description:
The M2a-Magnum™ ™ Tri-Spike™ Acetabular Components is a Co-Cr-Mo, full hemisphere shell in outer diameters of 44mm to 66mm designed for metal articulation. The outer surface of the shell features porous plasma spray coating for biological fixation and three dome spikes for rotational stability.
Intended Use: The M2a-Magnum™ System is indicated for non-cemented use in patients requiring total hip replacement due to the following:
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic . variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
- . 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 of previously failed total hip arthroplasty
Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device
Non-Clinical Testing: None provided
Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
| MAILING ADDRESS | P.O. Box 587Warsaw, IN 46581 0587 |
|---|---|
| SHIPPING ADDRESS | 56 E. Bell DriveWarsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| biomet@biomet.com |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-1683
OCT 3 1 2006
Re: K062995 Trade/Device Name: M2a-Magnum™ Tri-Spike Acetabular Component Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component Regulatory Class: Class III Product Code: KWA Dated: September 29, 2006 Received: October 02, 2006
Dear Ms. Sandborn 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,
Mark N. Melkerson
Mark N. Melkerson 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):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The M2a-Magnum™ System is indicated for non-cemented use in patients requiring total hip replacement due to the following:
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
- 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 of previously failed total hip arthroplasty
Prescription Use (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) | |
|---|---|
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Pep
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062997 Page 1 of 1
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§ 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.