(29 days)
Not Found
No
The document describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for use in hip replacement and treatment of various hip conditions, directly addressing and improving a health condition.
No
Explanation: The device described is a femoral stem for hip replacement surgery. Its intended use is for treatment, not diagnosis, of various hip conditions.
No
The device description explicitly states the device is composed of titanium alloy and describes physical characteristics and coatings, indicating it is a hardware implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a femoral stem, which is a component of a hip replacement system. This is a surgically implanted device used to replace a damaged hip joint.
- Intended Use: The intended use clearly states that the device is for use in individuals undergoing primary surgery for hip replacement due to various conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems 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.
AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.
Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LWJ, MEH, LZO
Device Description
AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper.
- 12/14 P-Series model has a plasma-spray surface enhancement.
- 12/14 L-Series model has a corundum finish.
Both models have a hydroxyapatite (HA) coating option. The femoral stems are intended [illegible text] models without the HA coating may be used with bone cement at the discretion of the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Empirical testing and engineering analyses were conducted. Based on successful results it was concluded that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.
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.
Not Found
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Exactech
JUN 2 1 2005
FL 32653
FAX 352-378-2617
Exactech® AcuMatch 12/14 Press-Fit Femoral Stems
510(k) Summary of Safety and Effectiveness Special 510(k)
Trade or proprietary or model name(s):
AcuMatch 12/14 P-Series Press-Fit Plasma Femoral Stems AcuMatch 12/14 L-Series Press-Fit Femoral Stems
Information on devices to which substantial equivalence is claimed:
| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| Number | ||
| K041906 | AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems | |
| AcuMatch 12/14 L-Series Press-Fit Femoral Stems | Exactech, Inc |
INDICATIONS
All Exactech Hip Systems 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.
AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.
Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Special 510(k) Modifications
The AcuMatch 12/14 Press-Fit femoral stems were modified from the predicate as follows:
- The geometry of the insertion hole feature was modified from an oblong slot to an . oblong slot with threads (P-Series only).
- The tolerance of the 12/14 taper threadform geometry was expanded. .
- Collared 12/14 P-Series Press-Fit Stem option was added. .
Rev. 05/19/05
1
Exactech
Image /page/1/Picture/1 description: The image shows an address written in cursive and print. The address is "Kari 1335 2320 NW 66TH COURT GAINESVILLE, FL 32653". The first line is written in cursive, while the rest of the address is printed.
FAX 352-378-2617
Exactech® AcuMatch 12/14 Press-Fit Femoral Stems
510(k) Summary of Safety and Effectiveness Special 510(k)
AcuMatch 12/14 Press-Fit Femoral Stems
AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper.
- 12/14 P-Series model has a plasma-spray surface enhancement. ●
- 12/14 L-Series model has a corundum finish. .
Both models have a hydroxyapatite (HA) coating option. The femoral stems are intended Doth models have a try are models without the HA coating may be used with bone cement at the discretion of the surgeon.
Conclusion:
Conclusion." results one clightering - 12:14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.
Rev. 05/19/05
Section 4 Page 3 of 3
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three lines forming its head and wings, giving it a modern and abstract appearance.
JUN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Maritza Elias Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K051335
Trade/Device Name: Exactech Acumatch 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353, 888.3350 Regulation Name: Hip joint metal/cemented/polymer semi-constrained cemented or nonregaration Names - Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JDI, LWJ, MEH, LZO Dated: May 17, 2005 Received: May 23, 2005
Dear Ms. Elias:
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 for doo based or 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 I ou mayy atch s 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 rr your de rise 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 r 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
3
Page 2 – Ms. Maritza Elias
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (seting your device as described in your Section 510(k) This letter will anow you to oegin mains of substantial equivalence of your device to a legally premarket notheadon. The PDF mining sitems of 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 acriously at (240) 276-0120. Also, please note the regulation entitled, Comaci the Office of Comphanes and in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation en Journer 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,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech®, Inc.
Exactech AcuMatch 12/14 Press-Fit Femoral Stems
Indications for Use
K051335 510(k) Number:
INDICATIONS
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals All Exactech Hip Systems are more to ass them to osteon thritis, the matoid
undergoing primary surgery for hip replacement due to steem of the hin, and for undergoing primary surgely for mp replacement we problems of the hip, and for arthritis, osteonecrosis, post-tradinatio copines where prosthetic replacement is determined by treatment of proximal remoral fractures when provins of Exactech Hip Systems are also
the surgeon as the preferred treatment. Components hip dysplassia, revision of the surgeon as the preletted treatinent. Configure on tall hip dysplass, revision of
potentially indicated for ankylosing spondylitis, congent, and to restore potentially indicated for allRylosing spondyinia, occaged is present, and to restore mobility resulting from previous fusion.
AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.
Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Prescription Use
X
Over the Counter Use _
Please do not write below this line - use another page if needed.
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Section 3 Page 1 of 1
05/18/05