(126 days)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The Zimmer M/L Taper Hip Prostheses are flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating. An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system.
Here's an analysis of the provided text regarding the Zimmer® M/L Taper Hip Prosthesis, focusing on acceptance criteria and study information:
Based on the provided document, the device described (Zimmer® M/L Taper Hip Prosthesis) is a medical implant in the orthopedic category, specifically for hip replacement. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared devices, rather than prove safety and effectiveness through extensive clinical trials for novel devices.
Therefore, the "acceptance criteria" and "study" described in the document are primarily focused on demonstrating substantial equivalence to predicate devices, rather than performance against a set of quantitative metrics for a new, innovative device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Material Equivalence | The device (Zimmer® M/L Taper Hip Prosthesis) is described as "flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating." This description is compared to the predicate devices. | The document doesn't explicitly list materials, but relies on the descriptor being substantially equivalent to the predicates. The mention of "titanium alloy plasma spray" and "Calcicoat Ceramic Coating" suggests material components that are likely consistent with predicate devices for hip prostheses. |
| Design/Function Equivalence | "An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system." | The core design (M/L Taper) is equivalent to its own previous versions (K032726, K042337) and other Zimmer products (K030265, K973714). The changes are incremental (additional sizes/neck lengths). |
| Intended Use/Indications Equivalence | The stated "Indications for Use" for both Total Hip Replacement and Hemi-hip Replacement are comprehensive and are implicitly accepted as equivalent to the predicate devices. | The FDA reviewed and accepted these indications as substantially equivalent. Examples include severe hip pain due to various arthritic conditions, avascular necrosis, fractures, failed endoprostheses, etc. |
| Non-Clinical Performance | "Analysis of the modified devices indicates that they are substantially equivalent to the predicates." | This statement confirms that non-clinical testing (which would typically involve mechanical, biocompatibility, and sterilization testing, etc., though not explicitly detailed here) was sufficient to demonstrate equivalence. No specific numerical performance criteria are provided in this summary. |
| Clinical Performance | "Clinical data and conclusions were not needed for this device." | This explicitly states that clinical trials demonstrating specific performance metrics were not required for this 510(k) submission due to substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There was no specific "test set" of patients or data evaluated for a de novo performance study. The assessment was based on comparing the device's design, materials, and intended use against existing predicate devices.
- Data Provenance: Not applicable for a clinical test set. The "data" used for demonstrating equivalence would be design specifications, material characterizations, and existing regulatory information from the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Given that "Clinical data and conclusions were not needed for this device," there was no "ground truth" to be established by panels of experts in the traditional sense of a clinical trial. The "experts" involved were likely internal Zimmer engineers and regulatory specialists, and subsequently, FDA reviewers who assessed the substantial equivalence claim.
- Qualifications of Experts: FDA reviewers are typically well-versed in engineering, medical device regulations, and relevant clinical fields, but their role here was not to establish clinical ground truth for a novel device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data and conclusions were not needed for this device." This type of study is typically performed to compare the diagnostic performance of a new medical imaging device or AI algorithm with human readers, and it is not relevant for a hip prosthesis 510(k) submission focused on substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a passive hip prosthesis, not an active device, diagnostic tool, or an AI algorithm. Therefore, "standalone performance" in the context of an algorithm or diagnostic device is irrelevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: In this 510(k) context, the "ground truth" is established by the legally marketed predicate devices. The new device's design, materials, and intended use are considered "true" in so far as they are substantially equivalent to these already-cleared devices, meaning they are considered safe and effective for their intended purpose. There is no external clinical ground truth (e.g., pathology, outcomes data) generated specifically for this submission.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of a hip prosthesis 510(k) submission. This concept applies primarily to machine learning algorithms or devices requiring iterative development based on data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there was no training set.
Summary of the Study and Acceptance Criteria for K060040:
The "study" supporting the Zimmer® M/L Taper Hip Prosthesis (K060040) was a non-clinical analysis to demonstrate substantial equivalence to already legally marketed predicate devices. The acceptance criteria were met by demonstrating that the modified device (an additional size and neck length option for an existing line) shares the same technological characteristics, intended use, and performs comparably in non-clinical assessments (as implied by the "Analysis of the modified devices indicates that they are substantially equivalent to the predicates") such that it raises no new questions of safety or effectiveness. No new clinical data or human-in-the-loop studies were required or conducted for this particular submission.
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K060040 (pg 1 of 2)
Summary of Safety and Effectiveness
MAY 12 2006
Contact Person:
Date:
Trade Name:
Common Name:
Classification Names and References:
Predicate Devices:
Device Description:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Karen Cain, RAC Manager, Corporate Regulatory Affairs Telephone: (574) 372-4219 Fax: (574) 372-4605
January 5, 2006
Zimmer® M/L Taper Hip Prosthesis
Total Hip Prosthesis
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR § 888.3358, product code LPH
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 21 CFR § 888.3353, product codes MEH, LZO
Zimmer® M/L Taper Hip Prosthesis, K032726, cleared October 22, 2003
Zimmer M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating, K042337, cleared November 4, 2004
Zimmer CPT® 12/14, K030265, cleared March 4, 2003
Zimmer VerSys® Beaded Mid-Coat Stem, K973714, cleared December 24, 1997
The Zimmer M/L Taper Hip Prostheses are flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The
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KO60040 (p) 2 of 2
prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating.
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head: pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system.
Non-Clinical Performance and Conclusions:
Analysis of the modified devices indicates that they are substantially equivalent to the predicates.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings and a base that resembles flowing water. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, with the words evenly spaced to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2006
Zimmer, Inc. c/o Ms. Karen Cain Manager, Corporate Regulatory Affairs P.O. Box 708 -Warsaw, Indiana 46581-0708
Re: K060040
Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, MEH, LZO Dated: April 13, 2006
Received: April 14, 2006
Dear Ms. Cain:
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
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Page 2 - Ms. Karen Cain
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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):
Device Name:
Zimmer® M/L Taper Hip Prosthesis
Indications for Use:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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KOSOD40 ***(k) Number
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.