(23 days)
Not Found
No
The document describes a mechanical implant (femoral stem and modular heads) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
The device is indicated for use in conditions like non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, and treatment of fractures, which are all conditions that therapeutic devices aim to treat or alleviate.
No
The provided text describes a medical device, the Taperioc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads, which are indicated for use in total hip replacement. The "Intended Use / Indications for Use" section outlines conditions for which the device is used (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis), and the "Device Description" details its physical characteristics and materials. There is no mention of the device being used to identify or determine the nature of a disease or condition, which would be the function of a diagnostic device. Instead, it is a therapeutic device used for treatment.
No
The device description clearly describes physical components made of titanium alloy, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a component for total hip replacement surgery. This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a femoral component (stem) and modular heads, which are implants designed to be surgically placed within the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The purpose is to replace a damaged joint.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Taperloc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads are indicated for use in non-cemented and/or cemented total hip replacement in cases of:
- 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 total joint replacement.
The Biomet Freedom® Constrained Modular Head is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or 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)
LPH
Device Description
The Taperloc® 12/14 Taper 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. A lateralized version of the device is available. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and the proximal third 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
Indicated Patient Age Range
Not Found
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: Engineering analysis has demonstrated equivalence between the Taperloc® 12/14 Taper 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.
K030055, K921301, K830313, K960984, K011110, K030047
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.
Not Found
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
§ 888.3358 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.
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K041537 pge 142
Image /page/0/Picture/1 description: The image shows the date "JAN 1 4 2005" in a simple, sans-serif font. Below the date is the word "BIOMET" in a stylized, blocky font. The letters are thick and geometric, with the "O" being a perfect circle and the other letters having a squared-off appearance.
510(k) Summary
Applicant/Sponsor:Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Taperloc® 12/14 Taper Femoral Components
Common Name: Total hip replacement device
Classification Names:
-
- Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (21 CFR 888.3358)
-
- Prosthesis, hip, semi-constrained, metal/polymer, porous coated, cemented (21 CFR 888.3350)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
K030055 - Expanded Indications for Non-cemented Porous Coated Total Hip Prosthesis
K921301 – Taperloc® Femoral Stem and Universal Acetabular Component
K830313 – CFE Total Hip Femoral Component – Porous Coated
K960984 - SHP Hip System
K011110 - M2a™ Acetabular System
K030047 - Freedom™ Constrained Liner
Device Description: The Taperloc® 12/14 Taper 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. A lateralized version of the device is available. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and the proximal third of each femoral stem is covered with Biomet's full plasma spray porous coating.
Intended Use: The Taperloc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads are indicated for use in non-cemented and/or cemented total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
- Rheumatoid arthritis 2)
MAILING ADDRESS PO. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E Roll Drive Warsaw, 1N 46582
t
OFFICE 574 267 6659 100
FAX 571 267 8137
E-MAIL biome1@biomet.com
1
pqe 24
510(k) Summary Taperloc® 12/14 Taper Femoral Components Biomet Manufacturing Corp.
- Correction of functional deformity 3)
- 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 total joint replacement. 5)
The Biomet Freedom® Constrained Modular Head is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or 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: Engineering analysis has demonstrated equivalence between the Taperloc® 12/14 Taper Femoral Components and the predicates.
Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines, which is a common symbol associated with the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2005
Ms. Patricia Sandborn Beres Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46582
Re: K043537
Trade/Device Name: Taperloc® 12/14 Taper Femoral components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: December 21, 2004
Received: December 22, 2004
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) This letter will and w yours ough timing of substantial equivalence of your device to a legally prematics notication. "The 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 If you dosire 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. Whoordinant of responsibilities under the Act may be obtained from the Other general Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. Mark N. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko44537
Indications for Use
510(k) Number (if known): K043537
Device Name: Taperloo® 12/14 Taper Femoral Components
Indications For Use:
The Taperioc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads are indicated for use in cemented or non-cemented total hip replacement in cases of:
- ated for doe in oomentoo joint disease including osteoarthritis and avascular 1) necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Conection of non-union, femoral neck fracture, and trochanteric fractures of the 4) rroximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed joint replacement. 5)
The Biomet Freedom® Constrained Modular Head is indicated for use as a component The blomet I recome ochetany and revision patients at high risk of dislocation due to of a lotal hip prostinolo in primary loss, joint or soft tissue laxity, neuromuscular a mistory of phor disionity, and for whom all other options to constrained acetabular components have been considered.
Prescription Use X (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)
ORH. Office of Device Evaluation (ODE)
Mark H. Milkern
(Division Sign-Off)
I. Restorative. and Neurological Devices
510(k) Number K043537
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