(23 days)
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:
- 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 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.
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.
The provided document K041537 outlines the 510(k) summary for the Taperloc® 12/14 Taper Femoral Components. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device overall design, materials, and processing methods are similar to predicate devices. | "The overall design, materials and processing methods are similar to the predicate device." (Page 2) |
| Mechanical/Engineering Safety | Engineering analysis demonstrates equivalence to predicates. | "Engineering analysis has demonstrated equivalence between the Taperloc® 12/14 Taper Femoral Components and the predicates." (Page 2) |
| Intended Use | Intended use aligns with legally marketed predicate devices. | Indications for use are provided and are consistent with predicate devices (e.g., total hip replacement for various conditions). The FDA's substantial equivalence determination implies acceptance of the stated indications. (Pages 1 & 4) |
| Biocompatibility | Materials conform to ASTM standards (implied safety). | "manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472" (Page 1) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission states "Clinical Testing: None provided" (Page 2). This indicates that no human clinical data (which would involve a "test set" of patients) was used to demonstrate the device's performance for this 510(k) submission. The equivalence was established through non-clinical engineering analysis and comparison to predicate devices.
- Data Provenance: Not applicable. Since no clinical testing was performed, there is no provenance for a clinical test set. The data presented is from internal engineering analyses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical test set was used, and therefore no ground truth derived from expert review of patient data. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices, which were deemed safe and effective through prior regulatory processes.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is a physical medical implant (femoral component for hip replacement), not an AI-assisted diagnostic or treatment system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm, so a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- For this 510(k) submission, the "ground truth" is primarily based on the established safety and efficacy of the predicate devices. The new device demonstrates substantial equivalence by showing that its design, materials, and performance are similar to devices already legally marketed and proven (through their own regulatory pathways, which may have included clinical data or extensive non-clinical testing). The engineering analysis supports this claim of equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML product that requires a "training set" in the conventional sense. The "training data" for the design and engineering principles would be decades of biomechanical research, material science, and performance data from similar hip implant designs, but this is not quantifiable as a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the AI/ML context. The design and manufacturing processes are likely informed by industry standards, engineering best practices, and the performance history of similar devices.
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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
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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.
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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.
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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) 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
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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
Page 1 of 1
§ 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.