(20 days)
The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.
We added 6 sizes, 28 S, 28 M, 28 L, 32 S, 32 M, and 32 L of ceramic ball heads to the SC Total Hip System, which was cleared for marketing by FDA on 10/15/03 (K031474). These ball heads allow the surgeon a further option to meet the patient's needs.
This document is a 510(k) summary for a medical device modification, specifically the addition of new sizes of SC Ceramic Ball Heads to an existing hip replacement system. It is a regulatory submission, not a study report, and therefore does not contain the detailed information typically found in clinical or performance studies.
Therefore, many of the requested sections (2-9) cannot be answered from the provided text as the information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties equivalent to other similar implants | "The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
Information Not Available in the Provided Text:
The following information is not present in the 510(k) summary, as it is a regulatory document focused on demonstrating substantial equivalence rather than a detailed report of a specific study's methodology:
- 2. Sample sizes for the test set and data provenance: No information on the actual number of ceramic ball heads tested, or where the data came from (e.g., country of origin, retrospective/prospective).
- 3. Number of experts used to establish ground truth and their qualifications: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 4. Adjudication method for the test set: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
- 7. The type of ground truth used: For biomechanical tests, the "ground truth" would be the measured physical properties. The document states "Biomechanical tests have been performed," but does not detail the specific measurements or reference standards used.
- 8. The sample size for the training set: Not applicable, as this was a biomechanical test, not an AI or machine learning study.
- 9. How the ground truth for the training set was established: Not applicable, as this was a biomechanical test, not an AI or machine learning study.
Summary of the Study (as described in the document):
The document refers to "Biomechanical tests" that were performed to demonstrate the equivalence of the new SC Ceramic Ball Heads to existing, similar implants. The study's conclusion, as stated, is that "The test results were equivalent to other similar implants and are sufficient for in vivo loading." This indicates the device met the implicit acceptance criteria of performing comparably to already cleared devices. However, the specifics of these tests (e.g., fatigue testing, static strength, wear resistance, the standards followed, the number of devices tested) are not detailed in this 510(k) summary. This type of information would typically be found in the full 510(k) submission, not in the publicly available summary.
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K052237 pge 191
SPECIAL 510(K) DEVICE MODIFICATION SC Ceramic Ball Heads August 16, 2005
SEP - 6 2005
510(k) Summary of Safety and Effectiveness [in accordance with SMDA of 1990, 21 CFR 807.92(c)]
Contact: Mr. Hartmut Loch Director, Regulatory Affairs & Official FDA Correspondent Orthopedic Alliance, LLC 41558 Eastman Drive, Suite A Murrieta, CA 92562 Tel: 951-304-9001 Fax: 951-304-9101
- Trade name: SC Ceramic Ball Heads
- Common name: Ceramic Ball Heads
Classification Hip Joint Metal/Ceramic/Polymer Semi-Constraint Cemented or Non-Porous Uncemented Prosthesis name:
Class II, Orthopedic Device Panel 87
Product Code: LZO
Device Description and Characteristics: We added 6 sizes, 28 S, 28 M, 28 L, 32 S, 32 M, and 32 L of ceramic ball heads to the SC Total Hip System, which was cleared for marketing by FDA on 10/15/03 (K031474). These ball heads allow the surgeon a further option to meet the patient's needs.
- Indications: The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.
Performance Biomechanical tests have been performed. The test results data: were equivalent to other similar implants and are sufficient for in vivo loading.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2005
Mr. Hartmut Loch Director, Regulatory Affairs Orthopedic Alliance, LLC 41558 Eastman Drive, Suite A Murrieta, California 92562
Re: K052237 Trade/Device Name: SC Ceramic Ball Heads 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 Dated: August 16, 2005 Received: August 18, 2005
Dear Mr. Loch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications relerenced above and nave determined with marketed predicate devices marketed in interstate for use stated in the enclosure) to tegans and the Medical Device Amendments, or to commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Costlience Act (Act) that do not require appear al controls provisions of the Act. The Y ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 above) also Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD a may be subject to subli additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tcase be advised that I DA 3 issualse over device complies with other requirements of the Act that I D7 has made a acted regulations administered by other Federal agencies. You must of ally rederal statutes and regulations canning, but not limited to: registration and listing (21 comply with an the Aot 3 requirements, mort 801); good manufacturing practice requirements as set CI K I att 607), lubomig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Hartmut Loch
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieing of substantial equivalence of your device to a legally prematication. The PDA miaing of casification 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 if you desire specific advice for your ac not to career and and and and and of the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain. Milsbraining by reference to premaintentibilities under the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SPECIAL 5,10(K) DEVICE MODIFICATION SC Ceramic Ball Heads August 16, 2005
1 1 Page of
K052237 510(k) Number:
SC Ceramic Ball Heads Device Name(s):
Indications for Use:
The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteorheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
No Over-The-Counter-Use (21 CFR 801 Subpart C)
(2, 571, 581, Support, 3)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
51000 Number K052237
§ 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.