(85 days)
Not Found
No
The summary describes a hip replacement system and its components, focusing on materials, fixation methods, and indications for use. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies described are standard engineering evaluations for mechanical properties, not AI/ML model performance.
Yes
The device is indicated for use in hip replacement due to various medical conditions, aiming to restore mobility and treat problematic hip issues, which aligns with the definition of a therapeutic device.
No
The device is a hip replacement system, indicated for use in treating various hip conditions, not for diagnosing them. Its purpose is to replace parts of the hip, not to identify diseases or conditions.
No
The 510(k) summary describes physical hip implant components (femoral stems, acetabular cups, femoral heads, endoprostheses) and their intended use and fixation methods. It also mentions performance studies involving empirical testing and engineering analyses of these physical devices. There is no mention of software as the primary or sole component of the device.
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 hip replacement system, which is an implantable medical device used in surgery. It is not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for surgical hip replacement due to various conditions affecting the hip joint.
- Anatomical Site: The anatomical site is the hip, indicating a device used within the body.
Therefore, based on the provided information, the Exactech Hip System is a surgical implant, not an In Vitro Diagnostic device.
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.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups 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.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI
Device Description
Not Found
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
Surgeon / Not Specified
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)
Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Cemented Femoral Stems and Novation Cemented Stems 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.
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
§ 888.3353 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.
0
DEC 2 7 2005
2320 NW 66TH COURT GAINESVILLE, FL 32653
352 377-1140 FAX 352-378-2617
Exactech® Inc. AcuMatch 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems 510(k) Summary of Safety and Effectiveness Special 510(k)
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 |
|---|---|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
Bennie Gladdish Contact: Hip Systems Manager/Principal Engineer
Date: September 27, 2005
Rev. 09/27/05
Section 4 Page 1 of 3
EXACTCH eight to inprove the politions by minibiling their octive ond integendence. We do this though innotive ides, high-quoting reduction on commitment to sense.
1
352 377-1140 FAX 352-378-2617
Exactech® Inc. AcuMatch 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems 510(k) Summary of Safety and Effectiveness Special 510(k)
Trade or proprietary or model name(s):
AcuMatch 12/14 C-Series Cemented Femoral Stems (Size 1-6) AcuMatch 12/14 L-Series Cemented Femoral Stems (Size 1-5) Novation Cemented Femoral Stems (Size 9,11,13,15,17)
Information on devices to which substantial equivalence is claimed:
| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| Number | ||
| K023646 | AcuMatch 12/14 C-Series Cemented Femoral Stems (Size 1-6) | Exactech, Inc. |
| K001335 | AcuMatch 12/14 L-Series Cemented Femoral Stems (Size 2-5) | |
| K011218 | AcuMatch 12/14 L-Series Cemented Femoral Stems (Size 1 ) |
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.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- Press-fit femoral stems and acetabular cups 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.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
Special 510(k) Modifications
The AcuMatch 12/14 C-Series Cemented femoral stems were modified from the predicate as follows:
- The femoral head/neck taper geometry was modified from Exactech's proprietary ● taper design to the "12/14 Euro-Style" threadform taper design
Rev. 09/27/05
Section 4 Page 2 of 3
2
352-377 1140 FAX 352-378-2617
Exactech® Inc.
AcuMatch 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems 510(k) Summary of Safety and Effectiveness
Special 510(k)
- The femoral neck length was decreased by 4mm .
- The femoral neck geometry was shifted medially by 1.5 mm .
- The geometry of the insertion hole feature was modified from a dimple to the oblong . slot.
- "12/14" Laser-etching was added to the face of the femoral stem taper .
The AcuMatch 12/14 L-Series Cemented femoral stems were modified from the predicate as follows:
- The femoral head/neck taper geometry was modified from Exactech's proprietary . taper design to the "12/14 Euro-Style" threadform taper design
- . The femoral neck length was decreased by 4mm
- The femoral neck geometry was shifted medially by 1.5 mm .
- . The geometry of the insertion hole feature was modified from a dimple to the oblong slot.
- . "12/14" Laser-etching was added to the face of the femoral stem taper.
- A cobra flange geometry was added .
- The material specifications for the L-Series cemented stem were changed from cast . Co-28Cr-6Mo (ASTM F75) to forged Co-28Cr-6Mo (ASTM F799).
The Novation Cemented femoral stems were modified from the predicate as follows:
- The femoral head/neck taper geometry was modified from Exactech's proprietary . taper design to a "12/14 Euro-Style" threadform taper design
- . The trapezoidal cross-sectional area was modified to a circulo-trapezoidal geometry.
- . A change to the sizing range and differential.
- The insertion hole feature was changed from a spherical dimple to the oblong slot .
- . A "12/14" Laser-etching was added to the face of the femoral stem taper.
Conclusion:
Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Cemented Femoral Stems and Novation Cemented Stems 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. 09/27/05
Section 4 Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three lines representing the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
Ms. Maritza Elias Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653
Re: K052787
Trade/Device Names: AcuMatch 12/14 Cemented Femoral Stems; Novation 12/14 Cemented Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, JDI Dated: November 22, 2005 Received: December 8, 2005
Dear Ms. Elias:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 910(t) premised is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreative to regars) the Medical Device Amendments, or to commerce prior to May 26, 1776, the enatinen with the provisions of the Federal Food, Drug, devices may been reculisomed in acces approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Cosmetic Act (Act) that to not requests appt o the general controls provisions of the Act. The You may, therefore, manel me devices, seejeer to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (sec above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA m may be subject to such additional controller Entroller - British - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 800 to 898. In additio be found in the Ood of I cases on cerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a bassaint in ther requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a delerimiation that Jour as roos by other Federal agencies. You must and listing and listing or any rederal statutes and regulations administrations of the registration and listing (21 left comply with an the Act stequirements, mercaing, and manufacturing practice requirements as set
4
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 (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k)
1999) 1992 – 1992 – 1992 – 19 – 1 – 1 – 1 – 1 – 1 – 1 (x) I his letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket notification. The PDA mailing of substanted by 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
rs the results of the county of 1100 - All and assesses the regulation enti If you desire specific advice for your do not of the other note the regulation entitled, contact the Office of Complaned at (210) 210-01-21 (21CFR Part 807.97). You may obtain "Misbranding by relevence to premanon noutheations.
other general information on your responsibilities under the Act from the 6800 638, 00 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistanto at on on corn/industry/support/index.html.
Sincerely yours,
Signature
a 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 12/14 Cemented Femoral Stems Novation 12/14 Cemented Femoral Stems
Indications for Use
510(k) Number:
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals An Exactoon rip Dysterery for hip replacement due to osteoarthritis, rheumatoid andergoing primary as post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also the surgeon as the presentation spondylitis, congenital hip dysplasia, revision of potentially marcated structions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- Press-fit femoral stems and acetabular cups 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.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
CONTRAINDICATIONS
Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, without barneten over that do not allow control of the hip joint, and in patients m nouromasounar disoration marvel would cause the surgeon to expect early failure of the whose weight, ago, et unipolar and bipolar endoprostheses are also contraindicated for System: "The E Berrer anipes of degenerative changes in the acetabulum and/or pelvic fractures.
Over the Counter Use or Prescription Use X
Please do not write-below this line - use another page if needed. Concurrence of CDBA, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, Section 3 09/27/05 and Neurological Devices Page 1 of 1 510(k) Numb