(210 days)
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a component of a hip prosthetic system intended to treat patients at high risk of hip dislocation, which is a therapeutic purpose.
No
This device is an implantable prosthetic component (constrained acetabular liner) for hip replacement surgery, falling under the category of a therapeutic device designed to mechanically constrain femoral heads. It does not perform any diagnostic function.
No
The device description clearly describes physical components (acetabular liners, constraining ring, acetabular shells, femoral heads, femoral stem components) and their mechanical assembly and function. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used within the body to treat hip dislocation. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The description details a physical component designed to be implanted in the hip joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic testing, or providing information about a disease or condition based on in vitro analysis.
This device is a medical device, specifically a prosthetic implant.
N/A
Intended Use / Indications for Use
Exactech AcuMatch A-Series® and MCS® constrained liners are components of the Exactech AcuMatch A-Series® or MCS® noncemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.
Product codes (comma separated list FDA assigned to the subject device)
87 KW7, KWZ
Device Description
Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners are designed for use with appropriately sized Exactech AcuMatch A-Series and MCS® acetabular shells. The Constrained Liners are designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. The constraining ring is mechanically assembled to a secure Exactech® acetabular shell. The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648. All rings are machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
The Exactech AcuMatch A-Series® Constrained Acetabular Liner & MCS® Constrained Acetabular Liner have been evaluated according to FDA guidance document entitled: Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA. The evaluation included a Risk Analysis and Comparison to Standards. Testing was done according to Consensus Standards.
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
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
OCT 4 - 2004
510(k) Summary Pursuant to 21 CFR 807.92
| 1. | Submitted By: | Exactech, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
|----|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Dr. Gary Miller
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 |
| 3. | Product: | Exactech AcuMatch A-Series® & MCS®
Constrained Acetabular Liners
21 CFR Section 888.3310
Hip joint metal/polymer constrained
cemented or uncemented prosthesis
Class II
Product Code 87 KW7 |
1
Description:
Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners are designed for use with appropriately sized Exactech AcuMatch A-Series and MCS® acetabular shells. The Constrained Liners are designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. The constraining ring is mechanically assembled to a secure Exactech® acetabular shell.
Intended Use:
Exactech AcuMatch A-Series® and MCS® constrained liners are components of the Exactech AcuMatch A-Series® or MCS® noncemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.
Technological Characteristics and Substantial Equivalence:
The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648.
All rings are machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.
2
The devices are identical to previously cleared Exactech AcuMatch® (K993082) and MCS® (K921114) Lincrs except for the femoral head constraining features. The devices are similar to the Ringloc Constrained Liner (K021728) from Biomet Orthopedics and the Epsilon Durasul Constrained Acetabular Liner (K030923) from Centerpulse Orthopedics.
Performance Testing:
The Exactech AcuMatch A-Series® Constrained Acetabular Liner & MCS® Constrained Acetabular Liner have been evaluated according to FDA guidance document entitled: Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA
The evaluation included a Risk Analysis and Comparison to Standards. Testing was done according to Consensus Standards.
Conclusions:
バ
The Exactech AcuMatch A-Series® & MCS® constrained Acetabular Liners are substantially equivalent to similar devices existing in the market in materials of construction, dimensions, and performance characteristics. It has been determined to be an effective design and when used according to instructions for use, is a useful and valuable device.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
OCT 4 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Simpson Senior Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K040601
Trade/Device Name: Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: June 30, 2004 Received: July 6, 2004
Dear Ms. Simpson:
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
4
Page 2 -- Ms. Lisa Simpson
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/dsma/dsmamain.html
Sincerely yours,
Ronald A. Williams, Ph.D., M.D.
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
5
Indications for Use Statement
| 510(k) Number: | K040601 |
|---|---|
| Device Name: | Exactech AcuMatch A-Series® & MCS® |
| Constrained Acetabular Liners | |
| Intended Use: | Exactech AcuMatch A-Series® and MCS® |
| Constrained Acetabular Liners are components of the | |
| Exactech AcuMatch A-Series® or MCS® non-cemented | |
| acetabular cup system. The device is intended for use in | |
| primary or revision patients at high risk of hip dislocation | |
| due to a history of prior dislocation, bone loss, soft tissue | |
| laxity, neuromuscular disease, or intra-operative instability | |
| and for whom all other options to constrained acetabular | |
| components have been considered. They are intended for | |
| press-fit fixation and compatible with Exactech press-fit or | |
| cemented femoral stem components. |
X Prescription Use (Per CFR 801.109)
Of
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milherson
Division Sign-Off
(Division Sign-Off) (Division Dig.)
Division of General, Restorative, and Neurological Devices
104060 1 Page 510(k) Number_