(85 days)
No
The 510(k) summary describes a material change and new sizes for an existing acetabular liner, with no mention of AI or ML in the device description, intended use, or any other section.
Yes
The device, an acetabular liner for total hip replacement, is intended to treat medical conditions like osteoarthritis, rheumatoid arthritis, and fractures, which makes it a therapeutic device.
No
Explanation: This device is an acetabular liner for hip replacement surgery, which is a therapeutic device used in treatment, not for diagnosing medical conditions.
No
The device description clearly states it is an acetabular liner, which is a physical implant component used in hip replacement surgery, not a software-only device.
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 device used within the body for surgical replacement of the hip joint. 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 device is described as an "acetabular liner," which is a component of a hip implant. This is a medical device used in surgery, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic testing, or providing information for diagnosis or monitoring of a disease state based on in vitro analysis.
Therefore, the AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, LZO, MEH, LWJ
Device Description
This Special 510(k) premarket notification describes a material change from the predicate AcuMatch® A-Series UHMWPE polyethylene acetabular liners to acetabular liners manufactured from Enhanced Polyethylene. Additionally 5 new sizes are being introduced to the A-Series system.
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
skeletally mature individuals
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)
Not Found
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
§ 888.3358 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.
0
K051556 p1/3
SEP - 6 2005
Summary of Safety and Effectiveness
Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner
| Sponsor: | Exactech® Inc.
2320 N.W. 66th Court
Gainesville, Florida 32653 |
|----------------------|--------------------------------------------------------------------------------|
| Phone: | (352) - 377 - 1140 |
| Fax: | (352) - 378 - 2617 |
| FDA Establishment #: | 1038671 |
| Contact: | Diana Taylor
Regulatory Representative |
| Date: | August 26, 2005 |
| Trade Name: | Exactech® AcuMatch® A-Series Connexion GXL
Enhanced UHMWPE Acetabular Liner |
| Common Name: | Total Hip Prosthesis Acetabular Component |
| Device Description: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis | C.F.R. | 888.3358 |
|---|---|---|---|
| Product Code: | LPH | Section | |
| Device Description: | Hip joint metal/polymer semi-constrained cemented prosthesis | C.F.R. | 888.3350 |
| Product Code: | JDI | Section | |
| Device Description: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | C.F.R. | 888.3353 |
| Product Code: | MEH | Section | |
| Device Description: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | C.F.R. | 888.3353 |
| Product Code: | LZO | Section | |
| Device Description: | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis | C.F.R. | 888.3360 |
| Product Code: | LWJ | Section |
Section 4
Page 1 of 3
1
Summary of Safety and Effectiveness
Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner
Intended Use / Indications:
AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
Contraindications:
AcuMatch® A-Series Enhanced Polyethylene Acetabular liners are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.
Description:
This Special 510(k) premarket notification describes a material change from the predicate AcuMatch® A-Series UHMWPE polyethylene acetabular liners to acetabular liners manufactured from Enhanced Polyethylene. Additionally 5 new sizes are being introduced to the A-Series system.
Packaging and Sterilization:
AcuMatch® A-Series Enhanced UHMWPE Acetabular Iiners are sealed in two Tyvek® pouches. The pouches are enclosed in a poly bag and placed into the outer carton. A tamper-resistant seals on the outer box contain the statement "sterile unless seal is broken". An outer product label is attached to the outer carton. The carton is then shrink-wrapped.
Products are terminally sterilized by a precision gamma irradiation dose of 25.2 - 30.8 kGy. The Sterility Assurance Level (SAL) is 10°.
Section 4 Page 2 of 3
2
Summary of Safety and Effectiveness
Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner
Legally Marketed Predicate Devices
| Model | Manufacturer | 510(k) # | Clearance
Date | Product
Code(s) |
|---------------------------------------------------------------------------------------------------|--------------|----------|-------------------|--------------------------------|
| AcuMatch® A-Series Porous
Coated Acetabular
Component | Exactech | K993082 | 11/19/1999 | LPH & JDI |
| AcuMatch® A-Series and
MCS Acetabular Shells &
Liners | Exactech | K040613 | 06/4/2004 | JDI, LPH &
MEH |
| AcuMatch® A-Series 36mm
Acetabular Liner, 12/14
Femoral Head and Press-Fit
Femoral Stems | Exactech | K041906 | 09/10/2004 | LPH, LZO,
MEH, LWJ
& JDI |
Conclusion:
The proposed AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are substantially equivalent to the predicate AcuMatch® A-Series Acetabular Liners of the same design, which have not had additional processing of the material. The proposed liners manufactured from enhanced material are expected to exhibit reduced wear, while maintaining suitable mechanical and physical properties.
Section 4 Page 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2005
Ms. Diana Taylor Manager, Regulatory Affairs Exactech®, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K051556 Trade/Device Name: AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners Regulation Number: 21 CFR 888.3358, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3360 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. Regulatory Class: II Product Code: LPH, JDI, LZO, MEH, LWJ Dated: August 09, 2005 Received: August 10, 2005
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your corrent for the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to econimer to may 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). and Cosmetic Pror (110) that to device, subject to the general controls provisions of the Act. The I va may, dierely mains 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 be subject to suen addrents regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2- Ms. Diana Taylor
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated of a budenian and other requirements of the Act ulat IDA has made a decormination and Journer Federal agencies. You must of ally if ederal statutes and regulations and limited to: registration and listing (21 comply will an the 11ct 5 requirements, as a manufacturing practice requirements as set CTN Fart 607), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (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) I his letter will anow you to begin halkening of substantial equivalence of your device to a legally premarket nothleadon: "The PDF misms sification 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 desire specific acritorior your as not 100 100 - Also, please note the regulation entitled, Comaci the Office of Compilance and (21CFR Part 807.97). You may obtain Misoraliding by releveloc to premainter withilities 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/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech®, Inc.
AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners
Indications for Use
510(k) Number:
Kossrlo
Device Name: AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners
Indications for Use:
AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
Contraindications:
AcuMatch® A-Series Enhanced Polyethylene Acetabular liners are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.
| Prescription Use | X | or | Over the Counter Use | |
|---|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- | -- |
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K051556 |
|---|---|
| Section 3 Page 1 of 1 |