100KGY E-POLY MAXROM ACETABULAR LINERS
Device Facts
| Record ID | K070364 |
|---|---|
| Device Name | 100KGY E-POLY MAXROM ACETABULAR LINERS |
| Applicant | Biomet, Inc. |
| Product Code | JDI · Orthopedic |
| Decision Date | May 3, 2007 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications
Device Story
Acetabular liners fabricated from ultra-high molecular weight polyethylene (UHMWPE) infused with Vitamin E; modified manufacturing process achieves higher cross-linking (100 kGy). Used as components in total hip arthroplasty; implanted by orthopedic surgeons in clinical settings. Device serves as bearing surface in hip joint replacement; provides wear resistance through cross-linked material properties. Benefits patients by restoring joint function and addressing degenerative or traumatic hip conditions.
Clinical Evidence
No clinical data provided. Substantial equivalence based on non-clinical laboratory testing.
Technological Characteristics
Material: Ultra-high molecular weight polyethylene (UHMWPE) per ASTM F-648. Features: Vitamin E infusion; 100 kGy cross-linking process. Application: Acetabular liners for hip arthroplasty. Compatibility: Cemented and uncemented hip prosthesis systems.
Indications for Use
Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric) requiring head involvement, or revision of failed total hip arthroplasty. Suitable for cemented and uncemented applications.
Regulatory Classification
Identification
A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Predicate Devices
- E-Poly™ (Vitamin E) Acetabular Liners (K050327)
Submission Summary (Full Text)
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K070364 page 1 of 2
Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are all capitalized and evenly spaced. The "O" in the word is a perfect circle, while the other letters are more angular. The overall impression is one of strength and stability.
# 510(k) Summarv
Preparation Date: February 5, 2007
Applicant / Sponsor: Biomet Manufacturing Corp. MAY - 3 2007
Contact Person: Tracy Bickel Johnson, RAC
Proprietary Name: 100 kGy E-Poly™ MaxRom™ Acetabular Liners
Common Name: UHMWPE Liners
## Classification Name(s):
- LPH- prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (888,3358); .
- JDI- prosthesis, hip, semi-constrained, metal/polymer, cemented (888.3350); �
- LWJ- prosthesis, hip, semi-constrained, metal/polymer, uncemented (888.3360); .
- . MAY- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish (888.3353)
- LZO- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous. . uncemented (888.3353)
## Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K050327- E-
Poly™ (Vitamin E) Acetabular Liners
Device Description: Biomet Manufacturing Corp. is modifying the manufacturing process of ultrahigh molecular weight polyethylene (UHMWPE) used in the fabrication of polyethylene acetabular components. The modified manufacturing process results in a higher cross-linked polyethylene. The highly cross-linked UHMWPE is infused with medical grade Vitamin E.
#### Intended Une:
- 1. Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Summary of Technologies: The intended use, indications, contraindications, and design specifications of the subject components remain identical to its predicate counterpart, with the exception of a manufacturing change. The raw material being utilized in the manufacture of both the subject and the predicate devices remains a ultra-high molecular weight polyethylene (UHMWPE) per ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced in order to create a higher cross-linked polyethylene. The safety and effectiveness of this cross-linked polyethylene in acetabular applications are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
Image /page/0/Picture/26 description: The image shows mailing and shipping addresses. The mailing address is P.O. Box 557, Monroe, WA 98272. The shipping address is 140 E. Main St. Monroe, WA 98272. There is also an office number listed as 360-794-6777.
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Page 2 of 2
# 510(K) Notification Biomet Manufacturing Corp. 100 kGy E-Poly™ MaxRom™ Acetabular Liners Page 2 of 2
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Tracy Bickel Johnson, RAC Manager, Regulatory Affairs P.O. Box 587 Warsaw, Indiana 46581-0587
MAY - 3 2007
Re: K070364
Trade/Device Name: 100kGy E-Poly™ MaxRom™ Acetabular Liners Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LWJ, LPH, MAY Dated: April 3, 2007 Received: April 4, 2007
Dear Ms. Johnson:
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. Tracy Bickel Johnson, RAC
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" (21 CFR 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/cdrl/industry/support/index.html.
Sincerely yours.
Barbara Buchum
Mark N. Melkerson 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
Ko703 510(k) Number (if known):
1 1 1 1
Device Name: 100kGy E-Poly™ MaxRom™ Acetabular Components
Indications For Use:
- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2) Rheumatoid arthritis.
- 3) Correction of functional deformity.
- 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5) Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
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)
Barbara Buchum
SIPPER Division of General, Restorative, and Neurological Devices
510(k) Number K070364
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