The Apex K1™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis 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 K1 Hip Stem consists of a rectangular tapered stem, and modular heads that connect to the tapered trunion on the neck. Four configurations are available for each size: standard and long lengths, each with standard and lateraliz ed necks. These configurations allow the user to choose a combination of stem and head components to appropriately fit the anatomy of the patient. The Apex K1 Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems are manufactured from titanium alloy, and can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems.

AI/ML Overview

The provided 510(k) summary for the Apex K1™ Hip Stem does not describe acceptance criteria, a study that proves the device meets specific acceptance criteria, or performance metrics in the way typically expected for AI/software-as-a-medical-device (SaMD) devices.

This document is for a medical implant (a hip stem), and the regulatory submission process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device primarily through:

Comparison of design and materials: Ensuring the new device has similar characteristics.
Bench testing: Addressing mechanical properties, fatigue, and biocompatibility.
Performance data: Often derived from established standards for orthopedic implants.

Therefore, many of the specific questions about acceptance criteria, sample sizes for test sets, expert ground truth, MRMC studies, and standalone performance for AI are not applicable to this type of device submission.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not present or relevant to this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy) typically associated with AI/SaMD. The "performance" for a hip stem is generally implied by its design, materials, and mechanical properties, which are shown to be substantially equivalent to 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)

Not applicable. This is a physical medical implant. There is no "test set" in the context of data for an algorithm. The "testing" involved would be mechanical and biocompatibility bench tests, not data analysis.

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)

Not applicable. This is a physical medical implant. The determination of "ground truth" (e.g., successful performance or safety) comes from engineering standards, material science, and clinical experience with similar implants, rather than expert consensus on data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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

Not applicable. This is a physical medical implant, not an AI or software device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's safety and effectiveness is established through:

Engineering design principles.
Material testing to industry standards (e.g., for fatigue, strength).
Biocompatibility testing.
Demonstration of substantial equivalence to predicate devices with a history of safe and effective use.
No specific "ground truth" is explicitly mentioned in the document in the context of data for an algorithm.

8. The sample size for the training set

Not applicable. This is a physical medical implant, not an AI/software device that uses a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary regarding the provided document:

The 510(k) summary for the Apex K1™ Hip Stem focuses on demonstrating substantial equivalence to predicate devices (SL-Plus® and SLR-Plus® hip stems, and Apex K2™ Hip System) based on:

Intended Use: Identical or very similar.
Design Features: Comparison of coated status, modularity (head vs. neck), surface finish, stem shape, etc.
Materials: Comparison of titanium alloys, head materials, and coatings.

The document states: "Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), and the Apex K2™ Hip System (K041950)." This is the core "study" and "acceptance criteria" mechanism for this type of device – proving that it is sufficiently similar to devices already on the market that have been deemed safe and effective. The FDA's letter confirms this "substantial equivalence determination."

Summary

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510(K) Summary

AUG 2 5 2006

K060072

Apex K1™ Hip Stem

April 13, 2006

Contact: Edward J. Cheal, Ph.D. 1. Submitter: OMNI life science, Inc. 1390-A Decision Street Vice President of Research Vista. CA 92081 (760) 734-1550 x413

2. Device Name

Proprietary Name:	Apex K1™ Hip Stem
Common Name:	Hip prosthesis, uncemented
Classification Names:	Hip prosthesis, semi-constrained, metal/polymer, and hip jointmetal/ceramic/polymer, uncemented prosthesis
Regulatory Class:	Class II per 21 CFR §888.3358 and §888.3353
Product Codes:	LPH and LZO

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

The femoral stems are manufactured from titanium alloy, and can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems.

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Image /page/1/Picture/1 description: The image shows the OMNI logo on the left side and the text "510(K) Summary" and "K060072" on the right side. The OMNI logo consists of the word "OMNI" in bold black letters and a circular graphic above it. The text "510(K) Summary" is in a smaller font size than the word "OMNI", and the text "K060072" is in a larger font size and is located below the text "510(K) Summary". A black line is present below the word "OMNI".

5. Predicate Device Comparison

Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), a nd the Apex K2™ Hip System (K041950). The table below compares the features and characteristics of the Apex K1 Hip Stem to these predicate devices:

	Apex K1™ HipStem	Apex K2™ HipStem (K041950)	SL-Plus® andSLR-Plus®(K001942, K021178)
INTENDED USE
Primary and revisionhip replacement, non-cemented use	Yes	Yes	Yes
DESIGN
Coated	Yes - plasmasprayed CP Ti	Yes - plasmasprayed CP Ti	No
Proximal coating (only)	Yes	Yes	NA
Modular head	Yes	Yes	Yes
Surface finish	Al-oxide grit blast	Al-oxide grit blast	Al-oxide grit blast
Modular neck	No	Yes	No
Tapered stem	Yes	Yes	Yes
Distal Cross-sectionalshape	Rectangular	Rectangular	Rectangular
Distal slot(s)	No	No	No
Distal flutes	No	No	No
MATERIALS
Titanium alloy stem	Yes (Ti-6Al-4V)	Yes (Ti-6Al-4V)	Yes (Ti-6Al-7Nb)
Cobalt chromium oralumina ceramic heads	Yes (both)	Yes (both)	Yes (both)
Titanium coating	Yes - unalloyed	Yes - unalloyed	No

The Apex K1 stem geometry is similar to the SL-Plus® and SLR-Plus® distributed by Plus Orthopedics. The most significant difference between these devices is that the Apex K2 stems employ modular necks (and heads), while the SL-Plus and SLR-Plus, and the subject device, have modular heads (only). Also the Apex K2 and Apex K1 stems have a plasma sprayed CP titanium coating on the proximal portion of the stem, whereas the SL-Plus and SLR-Plus stems are grit blasted with no plasma sprayed coating.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2006

Dr. Edward J. Cheal Vice President of Research OMNI life science, Inc. 1390-A Decision Street Vista, California 92081

K060072 Re:

Trade/Device Name: Apex K1 Hip Stem 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, LPH Dated: August 21, 2006 Received: August 22, 2006

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

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Page 2 - Dr. Edward J. Cheal

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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. 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), please contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson, M.S. 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

510(k) Number (if known): K060072

Device Name: Apex K1™ Hip Stem

Indications For Use:

ﺮ ﭘﺮ

The Apex K1 Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis 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. .

Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oarbara Buchnd of
Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K060072

Regulation Number and Section

§ 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.