(71 days)
The Osteolock™ Acetabular Shells are intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.
The Osteolock™ Acetabular Shells are available in outer diameters from 38-80mm in two millimeter increments. The shells are available in four styles: one with a north pole visualization hole, one without a north pole hole, one with screw holes, and one that is pre-assembled with the plastic inserts. The inner aspect of the shell has scalloped depressions which form part of the locking mechanism for the acetabular insert. All shells are manufactured from Titanium alloy conforming to ASTM-F136.
There is a Titanium plasma spray coating on the outer aspect of the shell to provide a roughened surface texture. This plasma spray coating is not a porous coating and, as such, this cup is intended to be press fit into the acetabulum.
There is an apical hole plug which may be used in the design with a north pole hole. This apical hole plug is press fit into the north pole hole after the acetabular cup has been seated. The apical hole plug is designed to close the north pole hole to reduce the possibility of polyethylene debris egress from this opening.
The provided text describes a 510(k) summary for the Osteolock™ Acetabular Shell System. It focuses on the device's design, materials, intended use, and substantial equivalence to previously marketed devices. However, it does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic AI device summary typically would.
Instead, the document highlights:
- Substantial Equivalence: The core of this 510(k) summary is establishing "substantial equivalence" to predicate devices based on intended use, materials, design, operational principles, and relative indications and contraindications. This is a regulatory pathway that generally relies on demonstrating similarity to already cleared devices rather than extensive novel performance studies.
- Assembly/Disassembly Testing and Plasma Spray Characterization: The only mention of any "testing" is for "Assembly/disassembly testing of the liner from the shell" and "characterization of the plasma spray coating." These are likely engineering and material characterization tests, not clinical performance studies with specific performance metrics such as sensitivity, specificity, or AUC.
- Postmarket Surveillance: The FDA letter explicitly requires postmarket surveillance studies under Section 522(a) of the Act, indicating that longer-term or real-world performance data would be collected after market clearance, not as part of the initial 510(k) submission to prove initial acceptance criteria.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving its fulfillment because such details are not present in the provided 510(k) summary for this type of medical device (an orthopedic implant). The focus for this device is on safety and effectiveness through substantial equivalence to existing devices, coupled with engineering and material specifications.
If this were an AI/diagnostic device, the summary would typically include detailed performance metrics and study designs as requested.
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510(k) Summary
JUL 3 0 1997
Proprietary Name: Osteolock™ Acetabular Shell System
Common Name: Acetabular Shell without Screw Holes
Classification Name and Reference: CFR 888.3353 This device is a component of a hip ioint, semi-constrained. metal/ceramic/polymer, cemented or non-porous uncemented prosthesis.
Proposed Regulatory Class: Class II
Device Product Code: OR(87)LZO
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070
Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 5/19/97
The Osteolock™ Acetabular Shells are intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. They are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.
The Osteolock™ Acetabular Shells are available in outer diameters from 38-80mm in two millimeter increments. The shells are available in four styles: one with a north pole visualization hole, one without a north pole hole, one with screw holes, and one that is pre-assembled with the plastic inserts. The inner aspect of the shell has scalloped depressions which form part of the locking mechanism for the acetabular insert. All shells are manufactured from Titanium alloy conforming to ASTM-F136.
There is a Titanium plasma spray coating on the outer aspect of the shell to provide a roughened surface texture. This plasma spray coating is not a porous coating and, as such, this cup is intended to be press fit into the acetabulum.
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There is an apical hole plug which may be used in the design with a north pole hole. This apical hole plug is press fit into the north pole hole after the acetabular cup has been seated. The apical hole plug is designed to close the north pole hole to reduce the possibility of polyethylene debris egress from this opening.
Assembly/disassembly testing of the liner from the shell was presented, along with characterization of the plasma spray coating.
The substantial equivalence of the Osteolock™ Shells is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Osteolock™ Acetabular Cup with Screw Holes (K903362); Vitalock® Solid Back Shells (K952397); Vitalock® Spiked Acetabular Shell (K953664); Osteolock™ CL Femoral Stem (K944592); and Osteonics' Arc Deposition Hip Components.
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Image /page/2/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 top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Manager, Requlatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
JUL 30 1997
Re : K971854 Osteolock™ Acetabular Shell System Regulatory Class: II Product Code: LPH Dated: May 19, 1997 Received: May 20, 1997
Dear Mr. Maas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with
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the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug ----Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a)(1)(C) the device cleared for marketing by this letter as requiring postmarket surveillance. The rationale for this decision is contained in the enclosed attachment.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850
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Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been ------approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803) .
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete an FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301 (q) (1) (C) of the Act (21 U.S.C. 331 (q) (1) (C) . Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note
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the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance ... at its toll-free number (800) 638-2041 or (301) 443-6597 or at "" its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Indications for Use
510(k) Number (if known):
K97/854/
Device Name: Osteolock™ Acetabular Shell System
Indications for Use:
The Osteolock™ Acetabular Shells are intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter Use |
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(Optional Format 1-2-96)
| (Division Sign-Off)Division of General Restorative Devices | |
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| 510(k) Number |
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.