BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS

K073102 · Biomet Manufacturing Corp · LZO · Nov 27, 2007 · Orthopedic

Device Facts

Record IDK073102
Device NameBIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
ApplicantBiomet Manufacturing Corp
Product CodeLZO · Orthopedic
Decision DateNov 27, 2007
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3353
Device ClassClass 2
AttributesTherapeutic

Intended 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: 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 by other techniques. 5. 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 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. The 100 kGy E-Poly™ Acetabular Liners are intended for cemented and uncemented applications with the following 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 by other techniques. 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications.

Device Story

Biolox® delta Ceramic Heads and 100 kGy E-Poly™ Acetabular Liners function as bearing surfaces in total hip arthroplasty. Ceramic heads feature highly polished spherical surfaces articulating against polyethylene liners; modular heads attach to metallic femoral stems via Biomet Type I taper. Used in clinical settings by orthopedic surgeons during hip replacement or revision procedures. Device provides stable joint articulation, restoring function and mobility in patients with degenerative joint disease, fractures, or oncology-related bone loss. Benefits include reduced wear and improved stability compared to failed prior implants.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified against parameters in the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems'.

Technological Characteristics

Modular hip prosthesis components. Bearing surface: Biolox® delta ceramic head; Liner: 100 kGy E-Poly™ (UHMWPE). Attachment: Biomet Type I taper to metallic femoral stem. Cemented or non-cemented application. No software or electronic components.

Indications for Use

Indicated for patients requiring total hip replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric), or revision of failed arthroplasty. Compatible with salvage/oncology systems for ligament deficiency, tumor resection, or trauma, and interlocking stems for severe proximal bone loss.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in large, bold, sans-serif font. Below that, in a smaller font, is the text "MANUFACTURING CORP." ### 510(k) Summary | Applicant/Sponsor: | Biomet Manufacturing Corp. | NOV 27 200 | |--------------------|----------------------------------------------------------------------|------------| | Contact Person: | Becky Earl<br>Regulatory Specialist | | | Proprietary Name: | Biolox® delta Ceramic Heads with 100kGy E-Poly™<br>Acetabular Liners | | Common or Usual Name: Ceramic Modular Heads/UHMWPE Liners Classification Name: Hip joint/ceramic/polymer semiconstrained cemented or non-cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K051411 and K061312; 100 kGy E-Poly™ Acetabular Liners-K070364 and K070399. Device Description: Biolox® delta 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. The 100 kGy E-Poly™ acetabular liners for the Biolox® delta Ceramic Heads are a larger size of the previously cleared 100 kGy E-Poly™ liners, K070364 and K070399. 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: - 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 by other techniques. - 5. Revision procedures where other treatment or devices have failed. Mailing Address We are PL 100000000 Shiming Address . Last P . . Philar W-6-33. IN440-752 {1}------------------------------------------------ 510(k) Summary Biolox® delta Ceramic Heads with 100kGy E-Poly™ Acetabular Liners Biomet Manufacturing Corp. Page 2 Specific indications for compatible components that can be used with the above modular heads include: Salvage/Oncology Hip and Total Femur System components 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. The 100 kGy E-Poly™ Acetabular Liners are intended for cemented and uncemented applications with the following 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 by other techniques. - 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications. 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). {2}------------------------------------------------ Image /page/2/Picture/1 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 eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA." The text is arranged around the circumference of the circle, emphasizing the department's role and national scope. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 7 2007 NOV 22 Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K073102 Trade/Device Name: Biolox® delta Ceramic Heads with 100 kGy E-Poly™ Acetabular Liners Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, JDI, LWJ, LPH, MAY Dated: November 1, 2007 Received: November 2, 2007 Dear Ms. Earl: 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. Becky Earl forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herems (2) consisted in your device as described in your Section 510(k) I mis icher will anow you to begin inding of substantial equivalence of your device to a legally premarket notification: "The Pro Print of Same of Cevice 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 rr you desire specific and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (210) 210 0126. Hilov, (21CFR Part 807.97). For questions regarding postmarket surveillance, premarket notification - (IT) - (ITice of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the at (210) 278 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 H. Milliman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known):__K073l02 Device Name: 100kGy E-Poly™ 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 by other techniques. - 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications Prescription Use X (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 A. Melkersen 510(k) Number Page 1 of 1 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known):_K073102. ### Device Name: 38mm Biolox® delta Ceramic Heads 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: - 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 by other techniques. - 5. 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. (K974558, K002757, K021380, K033871) 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. (K990830, K042774) Prescription Use X (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 N. Milliken Page 1 of 1 510(k) Number
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%