(87 days)
Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Exactech AcuMatch A-Series® & MCS® Acetabular Shells and Liners are designed for use with appropriately sized Exactech femoral stems and heads.
The metal shells are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. They are porous coated with titanium beads, a blast finish, or with hydroxylapatite.
The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648.
The provided document is a 510(k) Premarket Notification for medical devices, specifically for "Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical studies with detailed performance metrics and acceptance criteria as one would find for novel high-risk devices or software algorithms.
Therefore, the information requested in the prompt, which is typically found in studies for new or AI-based devices, is not present in this document. The document explicitly states:
- "Performance Testing: Testing for the Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners was performed for, and reviewed, in predicate device submissions. Design Control assessments did not indicate a need for additional testing for the line extensions which are the subject of this Special 510(k)."
- "The new sizes of Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are substantially equivalent to existing previously cleared devices in design, materials of construction, manufacturing, and other characteristics."
This indicates that no new performance studies were conducted for this specific 510(k) submission. Instead, the device's acceptable performance is inferred from its substantial equivalence to previously cleared predicate devices.
Given this, I cannot provide the requested table and study details as they are not available in the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a new test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used for this submission (as no new study was conducted).
- Sample size for a training set (as this is not an AI/software device).
- How ground truth for a training set was established.
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13
Premarket Notification - Special 510(k) Premarket Notification - Special 510(it)
Exactech AcuMatch A-Series " and MCS " Acetabular Shells and Liners
JUN 0 4 2004
510(k) Summary Pursuant to 21 CFR 807.92
| 1 | Submitted By: | Exactech, Inc. |
|---|---|---|
| 2320 N.W. 66th Court | ||
| Gainesville, FL 32653 |
Dr. Gary Miller 2. Contact: Executive Vice President of Research and Development Exactech, Inc. 2320 N.W. 66th Court
Gainesville, FL 32653 Phone: (352) 377-1140 Fax: (352) 378-2617
- Exactech AcuMatch A-Series® and MCS® 3. Product: Acetabular Shells and Liners
21 CFR Section 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis
Class II
Product Codes JDI, LPH, MEH
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K040613 213
Premarket Notification - Special 510(k) Premarket Nothication - Special 510(K)
Exactech AcuMatch A-Series " and MCS " Acetabular Shells and Liners
Description:
Exactech AcuMatch A-Series® & MCS® Acetabular Shells and Liners are designed for use with appropriately sized Exactech femoral stems and heads.
The metal shells are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. They are porous coated with titanium beads, a blast finish, or with hydroxylapatite.
The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648.
Intended Use:
Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Substantial Equivalence:
The devices are line extensions, identical to previously cleared Exactech AcuMatch® (K993082 & K000242) and MCS® (K921114 & K990197) Shells and Liners.
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Premarket Notification - Special 510(k) Fremarket NothCation - Special 510(x)
Exactech AcuMatch A-Series & and MCS ® Acetabular Shells and Liners
Performance Testing:
Testing for the Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners was performed for, and reviewed, in predicate device submissions. Design Control assessments did not indicate a need for additional testing for the line extensions which are the subject of this Special 510(k).
Conclusions:
The new sizes of Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are substantially equivalent to existing previously cleared devices in design, materials of construction, manufacturing, and other characteristics. The changes in the devices have been done under the control of Design Assurance, and no new unmitigated risks were identified for these line extensions. The predicate products have been shown to be an effective design, with an acceptable performance history.
The contents of this submission demonstrate that the device additions are eligible for review and clearance under the special 510(k) premarket notification process.
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are likely meant to represent a symbol or emblem associated with the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
-JUN 0 4 2004
Gary J. Miller, Ph.D. Executive Vice President of Research and Development Exactech, Inc. 2320 N.W, 66th Court Gainesville, Florida 32653
Re: K040613
Trade/Device Name: Exactech AcuMatch® A-series and MCS® Acetabular Shells and Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI, LPH, MEH Dated: May 6, 2004 Received: May 7, 2004
Dear Dr. Miller:
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 may or babyer to one 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 - Gary J. Miller, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter notification. The FDA finding of substantial equivalence of your device to a legally prematics modicate 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 11 you dome office of Compliance at (301) 594-4659. 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 other general 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/dsma/dsmamain.html
Sincerely yours,
Mark N Milburn
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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Indications for Use Statement
4640613-14 1
or
510(k) Number:
Device Name:
Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners
All Exactech Hip Systems are indicated for use in Intended Use: skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Prescription Use X (Per CFR 801.109)
Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mulkerson
Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040613
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.