The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; .
Correction of functional deformity; .
Congenital dislocation; .
Revision procedures where other treatments or devices have failed; .
Femoral neck and trochanteric fractures of the proximal femur. ●

Device Description

The Apex Modular™ Alumina Heads are manufactured of Biolox® forte alumina (high purity aluminum oxide ceramic) by CeramTec AG (Biolox® is a registered trademark of CeramTec AG). The bore on this ball was designed and tested for compatibility with the neck taper on the Apex Modular Hip Stem (K000788). These modular heads are available in 28 mm and 32 mm diameters, with three offset options for each head size: -3.5, 0, and +3.5 mm (28 mm diameter heads) and -4, 0, and +4 mm (32 mm diameter heads).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically the Apex Modular™ Alumina Femoral Head. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, this document does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria in terms of clinical or diagnostic performance.

The document focuses on demonstrating substantial equivalence to existing legally marketed devices (Smith & Nephew Biolox Alumina Ceramic Heads and Plus Orthopedics Biolox® forte Alumina Ceramic Heads) for regulatory approval. This is typically done by showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate devices.

The only "testing" mentioned is:

"Burst and fatigue testing of these alumina heads on the Apex Modular 12/14 taper have been completed as per the relevant FDA guidance document."

This refers to mechanical engineering tests to ensure the physical integrity and durability of the ceramic head, not studies related to diagnostic accuracy, clinical outcomes, or human reader performance.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as these details are not present in the provided text.

Summary

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Apex Modular™ Alumina Femoral Head

1. Submitter:	Apex Surgical, LLC12 Harding StreetSuite 202Lakeville, MA 02347	Contact
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2. Device Name

Proprietary Name:	Apex Modular™ Alumina Femoral Head
Common Name:	Ceramic femoral head
Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class:	Class II per 21 CFR §888.3353

3. Intended Use

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; .
Correction of functional deformity; .
Congenital dislocation; .
Revision procedures where other treatments or devices have failed; .
Femoral neck and trochanteric fractures of the proximal femur. ●

4. Device Description

August 27, 2000

Edward J. Cheal, Ph.D. Managing Director (508) 947-6500 (voice) (208) 248-8227 (fax)

510(K) Summary KO12918

NOV 2 7 2001

Image /page/0/Picture/18 description: The image shows the logo for Apex Surgical. The logo consists of a large, bold letter "A" followed by the words "Apex Surgical" in a slightly smaller font. The letters are all black, and the word "Surgical" has a trademark symbol next to it.

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Image /page/1/Picture/1 description: The image shows the logo for Apex Surgical. The logo consists of a large, stylized letter "A" on the left, followed by the words "Apex Surgical" in a bold, sans-serif font. The letters are all black, and there is a small trademark symbol to the upper right of the word "Surgical".

5. Predicate Device Comparison

Substantial equivalence is claimed to the Smith & Nephew Biolox Alumina Ceramic Heads and the Plus Orthopedics Biolox® forte Alumina Ceramic Heads. The table below r rodus and the features and characteristics of the Apex Modular Alumina Femoral Head to these predicate devices.

	Apex ModularAluminaFemoral Head	Smith &Nephew BioloxAluminaCeramic Heads(K981847 andK991162)	PlusOrthopedicsBiolox® forteAlumina Heads(K990261)
INTENDED USE
Primary and revisiontotal hip replacement	Yes	Yes	Yes
DESIGN
Taper design	12/14	12/14	12/14
Head diameters	28 and 32 mm	28 and 32 mm	28 and 32 mm
Offsets, 28 mm heads	-3.5, 0, +3.5 mm	0, +3.5, +7 mm	-3.5, 0, +3.5 mm
Offsets, 32 mm heads	-4, 0, +4 mm	0, +4, +8 mm	-4, 0, +4 mm
MATERIALS
Ceramic head	Alumina	Alumina	Alumina
Stem trunion	Titanium alloy	Ti alloy or CoCr	Ti alloy or CoCr

These predicate heads are produced by the same vendor (CeramTec AG), using the same material (Biolox® forte), as the subject device. Burst and fatigue testing of these alumina heads on the Apex Modular 12/14 taper have been completed as per the relevant FDA guidance document.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 7 2001

Edward J. Cheal, Ph.D. Managing Director Apex Surgical, LLC 12 Harding Street, Suite 202 Lakeville, Massachusetts 02347

Re: K012918

Trade/Device Name: Apex Modular Alumina Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: LZO Dated: August 27, 2001 Received: August 30, 2001

Dear Dr. Cheal:

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 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.

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Page 2 - Edward J. Cheal, Ph.D.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Mark N. Milken

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

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Indications For Use Device Name: Apex Modular™ Alumina Femoral Head KO12918

The Apex Modular™ Alumina Femoral Head is intended for use in combination with the The Apex Modular Hip Stem as the femoral component in total hip replacement procedures. Apex Modular Hip Otom as the rended to articulate with a polyethylene or metal-backed This ceramic nead in intended to annonent. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

ation, and may be decenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; .
Correction of functional deformity; ●
Congenital dislocation; .
Oongonitar arocedures where other treatments or devices have failed; .
Femoral neck and trochanteric fractures of the proximal femur. .

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Millman

sion of General, Restorative

51 ( ) Number.

Prescription Use X (Per 21 CFR §801.109) Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.