(158 days)
No
The document describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip replacement component, used to treat medical conditions like osteoarthritis and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure diseases.
No
The device is a femoral component for hip replacement, used in treatment rather than diagnosis.
No
The device description clearly states that the device is a physical femoral stem made from titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (femoral components for hip replacement) that is physically placed within the patient's body. Its intended use is to replace a damaged hip joint due to various conditions.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the human body. The device itself is the treatment.
Therefore, based on the provided information, the Lateralized Taperloo® Microplasty™ Femoral Components are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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 Taperloc® 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.
Product codes (comma separated list FDA assigned to the subject device)
KWA, KWZ, JDL, JDI, LZO, MEH, LPH, MBL, KWY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (proximal femur, acetabulum)
Indicated Patient Age Range
Skeletally mature individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Mechanical testing has demonstrated equivalence between the Lateralized Taperloc® Microplasty™ Femoral Components and the predicates.
Clinical Testing: None provided
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
2
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.
3
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
4
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