(57 days)
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.
AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation.
Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.
The Exactech 12/14 Total Hip System includes AcuMatch 12/14 Press-Fit Femoral Stems, AcuMatch 12/14 CoCr Femoral Heads, and AcuMatch A-Series Acetabular Component (36mm I.D.). The femoral stem tapers were modified to a "12/14 Euro-style" design. A 36 mm line of femoral heads and mating acetabular liners was added.
12/14 CoCr Femoral Heads are composed of cobalt chromium alloy conforming to ASTM F1537. The femoral stem taper connection was modified to a 12/14 Euro-style taper design.
AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper. The P-Series model is available with a porous bead or plasma-spray surface enhancement. The L-Series model has a corundum finish. Options include collared and non-collared versions and hydroxapatite (HA) coating. The components are intended for press-fit applications. Modifications were made to the femoral neck length, femoral neck geometry, insertion hole feature, and laser-etching. A "High Offset" version was added to the P-Series Plasma product line.
The 36 mm AcuMatch A-Series Acetabular Liners are a line extension designed to mate with A-Series Acetabular "shell" components (A-Series Porous Acetabular Shells and A-Series Corundum Acetabular Shell). Each liner has a size designation (H, J, or K) that matches it to the correct mating shell component. The new 36 mm A-Series Acetabular liners are designed to articulate with the Exactech 12/14 36mm cobalt chromium femoral heads.
All Exactech implant components are provided as sterile, single use only to a sterility assurance level (SAL) of 10^-6.
The provided text is a 510(k) summary for the Exactech® 12/14 Total Hip System. It describes modifications to existing Exactech devices and claims substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or a study that directly proves the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy.
The summary focuses on:
- Device Modifications: Changes to femoral stem tapers, addition of a 36mm femoral head and mating acetabular liners, reduced femoral neck length, shifted femoral neck geometry, modified insertion hole feature, and added laser-etching.
- Materials: Specific materials used (cobalt chromium alloy, titanium alloy).
- Indications for Use: The conditions for which the hip system is intended.
- Conclusion: A general statement about "testing and engineering evaluations" conducted to verify adequate performance for anticipated in vivo use, concluding substantial equivalence.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's an attempt to answer the questions based on the available information and, where information is missing, to explicitly state its absence:
1. A table of acceptance criteria and the reported device performance
The document states: "Testing and engineering evaluations were conducted to verify that the performance of the new Exactech 12/14 Total Hip System components would be adequate for anticipated in vivo use." It also mentions "successful results" from these evaluations. However, no specific acceptance criteria or quantitative performance metrics (e.g., in terms of range of motion, wear rates, fracture resistance thresholds, or clinical success rates) are reported in this 510(k) summary.
The evaluation appears to be based on an assessment of substantial equivalence to predicate devices, rather than meeting novel performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The overarching criterion seems to be "adequate for anticipated in vivo use" and "substantially equivalent to Exactech's predicate devices." | "Testing and engineering evaluations were conducted to verify that the performance... would be adequate for anticipated in vivo use." "Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "testing and engineering evaluations," which typically involve bench testing (e.g., mechanical strength, fatigue, wear) rather than human clinical trials for a 510(k) submission for an orthopedic implant unless there are significant new safety questions. If clinical data were used, the sample size and provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. For orthopedic implants submitted via 510(k) and relying on substantial equivalence, the "ground truth" is typically defined by established material standards (e.g., ASTM F1537 for cobalt chromium, ASTM F1472 for titanium alloy) and predicate device performance, not expert clinical consensus on a test set in the same way it would be for a diagnostic AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where there might be disagreement, which is not described as part of this submission. The "evaluation" mentioned is likely internal engineering or bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. An MRMC study is not relevant for an orthopedic implant device submission. This type of study is for evaluating diagnostic accuracy or reader performance with an AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is an orthopedic implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic studies (expert consensus, pathology, outcomes data) is not directly applicable here. For an orthopedic implant, the "ground truth" for evaluating substantial equivalence would relate to:
- Material properties: Conformance to ASTM standards (e.g., F1537, F1472).
- Mechanical performance: Bench testing demonstrating comparable strength, fatigue resistance, and wear characteristics to predicate devices and acceptable levels for in vivo use.
- Biocompatibility: Assumed through use of well-established, previously cleared materials.
The document implicitly relies on these engineering and material-based "truths" to support its claims of safety and effectiveness.
8. The sample size for the training set
This information is not applicable and not provided. This device is an orthopedic implant, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not applicable and not provided. (See point 8).
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Exactech®
P. 1/4
2320 NW 66TH COUF GAINESVILLE, FL 3265
352 377 1140 FAX 352-378-2617
Exactech® 12/14 Total Hip System
SEP 1 0 2 )04
510(k) Sunnmary 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
Gary J. Miller Contact: Exec. V.P. of Research & Development
August 17, 2004 Date:
Rev. 08 17 04
{1}------------------------------------------------
$\mathbb{R}^{n+1} \rightarrow \mathbb{R}^n$
Exactech® 12/14 Total Hip System
510(k) Summary of Safety and Effectiveness Special 510(k)
Trade or proprietary or model name(s):
AcuMatch 12/14 Press-Fit Femoral Stems AcuMatch 12/14 CoCr Femoral Heads AcuMatch A-Series Acetabular Component (36mm I.D.)
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K030236 | AcuMatch P-Series Press-Fit Porous Femoral Stem | Exactech, Inc. |
| K002141 | AcuMatch P-Series Press-Fit Plasma Femoral Stem | Exactech, Inc. |
| AcuMatch L-Series Press-Fit Femoral Stem | ||
| K862234 | Exactech CoCr Femoral Head | Exactech, Inc. |
| K964262 | Exactech CoCr Femoral Head | Exactech, Inc. |
| K993082 | AcuMatch A-Series Acetabular Liners | 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.
AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation.
Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.
{2}------------------------------------------------
Exactech® 12/14 Total Hip System
510(k) Summary of Safety and Effectiveness Special 510(k)
Special 510(k) Device Modifications
The femoral stem tapers on predicate Exactech total hip system components were modified from a proprietary Exactech design to a "12/14 Euro-style" design. A 36 mm line of femoral heads and mating acetabular liners was also added to the system. As such, each component covered in the "Special 510(k)" represents a design change to an Exactech predicate device.
12/14 CoCr Femoral Heads
12/14 CoCr Femoral Heads are composed of cobalt chromium alloy conforming to ASTM F1537 (warm worked condition). The femoral stem taper connection was modified from a proprietary Exactech taper design to a 12/14 Euro-style taper design. This allows for compatibility with Exactech 12/14 femoral stem components.
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. The P-Series model is available with a porous bead or plasma-spray surface enhancement. The L-Series model has a corundum finish. Options include collared and non-collared versions and hydroxapatite (HA) coating. The components are intended for press-fit applications.
The AcuMatch Press-Fit femoral stems were modified as follows:
- 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 "High Offset" version was added to the P-Series Plasma product line. .
36 mm AcuMatch A-Series Acetabular Liners
The A-Series 36mm liners are a line extension to the current A-Series product line. The new liners are designed to mate with A-Series Acetabular "shell" components. This includes the A-Series Porous Acetabular Shells (K993082) and the A-Series Corundum Acetabular Shell (K000242). Each liner has a size designation (H, J, or K) that matches it to the correct mating shell component. The new 36 mm A-Series Acetbular liners are designed to articulate with the Exactech 12/14 36mm cobalt chromium femoral heads.
All Exactech implant components are provided as sterile, single use only to a sterility assurance level (SAL) of 10°6.
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Koy|7uL
- 4/4
Exactech® 12/14 Total Hip System
510(k) Summary of Safety and Effectiveness Special 510(k)
Conclusion:
Conclusion.
Testing and engineering evaluations were conducted to verify that the performance of the new Exactech 12/14 Total Hip System 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 devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird with three wing-like shapes extending from its body. The bird is positioned above a wavy line, possibly representing water or a horizon.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Gary J. Miller, Ph.D. Executive Vice President of Research & Development Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653
Re: K041906 Trade/Device Name: Exactech 12/14 Total Hip System Regulation Number: 21 CFR 888.3358, 888.3353, 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis; Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Code: LPH, LZO, MEH, LWJ, JDI Dated: August 17, 2004 Received: August 19, 2004
Dear Dr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered provises in 113) 2011 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetter for , market the device, subject to the general controls provisions of the Act. The 1 ou may, dicrores, 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 If your device is exactive (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 or any I 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
{5}------------------------------------------------
Page 2 - Gary J. Miller, Ph.D.
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 premained notification " 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 (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 Echeral 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 Millerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Exactech®, Inc.
Exactech 12/14 Total Hip System
Indications for Use
#K041906 510(k) Number:
INDICATIONS
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals All Exacteen Inp Bystems are mais replacement due to osteoarthritis, theumatoid
undergoing primary surgery for hip replacement due to osteoarthritis, i undergoing primary surgery for mp rophoses.
arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for arthritis, osteonectosis, post trainates where prosthetic replacement is determined by treatment of proximal femoral mactared with of Exactech Hip Systems are also the surgeon as the proferod a oaimes.
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.
AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation.
Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) Fress-In acclabular shells and process at the discretion of the surgeon.
Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.
| 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
| Rev. 08 18 04 | |
|---|---|
| 510(k) Number | K041906 |
| Section 3Page 1 of 1 | |
|---|---|
| -- | -------------------------- |
§ 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.