(158 days)
The Lateralized Taperloo® Microplasty™ Femoral Components are indicated for use in patients requiring hip replacement due to the following:
- Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis
- 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 femoral head resurfacing component
The Lateralized Taperioc® Microplasty™ Femoral Components are intended for uncemented use only.
Specific indications for compatible components that can be used with the Lateralized Taperloc® Microplasty™ femoral Components include:
Constrained Liners (K030047)
Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or revision surgery at high risk of hip dislocation due to history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
The Lateralized Taperloc® Microplasty™ Femoral Components are straight, collarless, flat, tapered stems designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 5.0mm to 25.0mm diameters. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and a proximal portion of each femoral stem is covered with Biomet's full plasma spray porous coating.
The provided text is a 510(k) summary for the Biomet Lateralized Taperloc® Microplasty™ Femoral Components. This document discusses the device's description, intended use, and substantial equivalence to a predicate device, primarily based on non-clinical testing. The document explicitly states that no clinical testing was performed or provided.
Therefore, it is not possible to complete the requested table and detailed study information as there is no clinical study described in the provided text that proves the device meets acceptance criteria. The device's clearance was based on demonstrating substantial equivalence through non-clinical mechanical testing to a legally marketed predicate device.
Here's a breakdown of why the requested information cannot be provided based on the input:
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Acceptance Criteria and Reported Device Performance: This would typically involve clinical endpoints (e.g., success rates, complication rates) and their corresponding performance metrics from a clinical study. Since no clinical study was performed, there are no reported device performance figures of this nature. The "acceptance criteria" for a 510(k) without clinical data primarily relate to demonstrating substantial equivalence in design, materials, manufacturing, and non-clinical performance (e.g., mechanical strength, wear resistance) compared to a predicate device.
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Sample Size, Data Provenance: No clinical study, therefore no sample size, test set, or data provenance.
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Number of Experts, Qualifications, Adjudication Method: These points are relevant to establishing ground truth in clinical studies, particularly for imaging or diagnostic devices. Not applicable here.
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MRMC Comparative Effectiveness Study: No clinical study, so no MRMC study.
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Standalone Performance: This refers to the algorithm's performance in AI/diagnostic devices. Not applicable to a hip implant.
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Type of Ground Truth: In clinical studies, this refers to the definitive diagnostic label (e.g., pathology, clinical outcome). Not applicable here as there is no clinical study data.
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Sample Size for Training Set, Ground Truth for Training Set: These are relevant for AI/machine learning models. Not applicable to a physical hip implant device.
Conclusion based on the provided document:
- Acceptance Criteria: Not explicitly detailed in terms of clinical performance metrics because no clinical testing was performed. The implicit acceptance criteria were demonstrating substantial equivalence through non-clinical mechanical testing, materials, and design similarity to the predicate device (Taper 2 TM Porous femoral Stem - K050441).
- Study Proving Acceptance Criteria: A "Non-Clinical Testing" study was performed.
- Description: "Mechanical testing has demonstrated equivalence between the Lateralized Taperloo® Microplasty™ Femoral Components and the predicates."
- Details regarding study: The document does not provide details about the specific mechanical tests, their protocols, acceptance thresholds, or results beyond the general statement of equivalence.
- Clinical Testing: "None provided."
The 510(k) clearance was based on the FDA's determination of substantial equivalence to a predicate device, supported by non-clinical (mechanical) testing, rather than a clinical study proving specific performance acceptance criteria for the new device.
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K062994 (pg 1 of 2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics Inc. The word "BIOMET" is in large, bold, sans-serif font. Below that, in a smaller, lighter font, is the text "ORTHOPEDICS INC."
510(k) Summary
Date Prepared: March 7, 2007 MAR 0 9 2007
Applicant/Sponsor:Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Lateralized Taperloc® Microplasty™ Femoral Components
Common Name: Total hip replacement device
Classification Name:
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR 888.3330) Product Code: KWA
Subsequent Product Codes:
KWZ, JDL, JDI, LZO, MEH, LPH, MBL, KWY
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Taper 2 TM Porous femoral Stem - K050441
Device Description: The Lateralized Taperloc® Microplasty™ Femoral Components are straight, collarless, flat, tapered stems designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 5.0mm to 25.0mm diameters. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and a proximal portion of each femoral stem is covered with Biomet's full plasma spray porous coating.
Intended Use: The Lateralized Taperloc® Microplasty™ Femoral Components are indicated for use in patients requiring hip replacement due to the following:
- Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
- Rheumatoid arthritis 2)
-
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4) the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed femoral head resurfacing component
Warshy, IN 10581-0587-0587 - 13-2 - Warsaw, Sturt, Dell, Dell, Dell, Dell, Delt, Delt, Dell, Delt, Delt, Delt, Dell, Delting,
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K062994 (pg. 2 of 2)
The Lateralized Taperloo® Microplasty™ Femoral Components are intended for uncemented use only.
Specific indications for compatible components that can be used with the Lateralized Taperloc® Microplasty™ femoral Components include:
Constrained Liners (K030047)
Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or revision surgery at high risk of hip dislocation due to history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device
Non-Clinical Testing: Mechanical testing has demonstrated equivalence between the Lateralized Taperloo® Microplasty™ Femoral Components and the predicates.
Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corporation c/o Ms. Patricia Sandborn Beres Senior Regulatory Specialist MAR 0 3 2007 56 East Bell Drive Warsaw, Indiana 46582 Re: K062994 Trade/Device Name: Lateralized Taperloc® Microplasty 100 Femoral Components Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. Regulatory Class: Class III Product Code: KWA, KWZ, JDL, JDL, LZO, MEH, LPH, MBL, KWY Dated: February 14, 2007 Received: February 15, 2007
Dear Ms. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Mulkerson
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
510(k) Number (if known): K062994
Device Name: Lateralized Taperloc® Microplasty™ Femoral Components
Indications For Use:
The Lateralized Taperloo® Microplasty™ Femoral Components are indicated for use in patients requiring hip replacement due to the following:
- Non-inflammatory degenerative ioint disease including osteoarthritis and avascular 1) necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 4) proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed femoral head resurfacing component 5)
The Lateralized Taperioc® Microplasty™ Femoral Components are intended for uncemented use only.
Specific indications for compatible components that can be used with the Lateralized Taperloc® Microplasty™ femoral Components include:
Constrained Liners (K030047)
Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or revision surgery at high risk of hip dislocation due to history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
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)
Mark N. Milken
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number
§ 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.