The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restorations Modular System include:

. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, and
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Device Description

The Restoration® Modular Hip System is a modular hip system comprise of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing 19mm Cone Body and adds a new style of proximal body called the MT3 body for use with the previously cleared distal stem components

AI/ML Overview

The provided document is a 510(k) summary for the Restoration® Modular System, a medical device for hip arthroplasty. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details (like MRMC or standalone performance), because a 510(k) for device modifications typically relies on mechanical testing and comparison to predicates, not extensive clinical trials with human readers or AI algorithms.

The document primarily focuses on:

Device Description: The Restoration® Modular System is a modular hip system comprising different proximal body styles and three distal stem designs, assembled by the surgeon. This submission modifies an existing 19mm Cone Body and adds a new MT3 body.
Intended Use: For primary or revision total hip arthroplasty, and in the presence of severe proximal bone loss. Indications include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, revision procedures, and treatment of nonunion, femoral neck, and trochanteric fractures.
Substantial Equivalence: The new components are deemed substantially equivalent to a predicate device in intended use, materials, and design. Mechanical testing was conducted to prove mechanical strength equivalence. Manufacturing methods, packaging, and sterilization are identical to the predicate.

In summary, none of your requested information (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is available in this 510(k) submission, as it pertains to a physical orthopedic implant modification and not an AI/software device that would undergo such evaluation.

Summary

{0}------------------------------------------------

page lofa

510(k) Summary of Safety and Effectiveness for the Modifications to the Restoration® Modular System

K040734

Proprietary Name:	Restoration® Modular System
-------------------	-----------------------------

Femoral Hip Prosthesis Name:

Regulatory Class: Class II

Classification Names and References:

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888 3353,

Prosthesis, hip, semi-constrained, metal/polymer, uncemented, 21 CFR §888.3350

Hip joint metal/polymer semi-constrained cemented prosthesis, 21 CFR §888.3350

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, 21 CFR §888.3358

Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicumphosphate

Hip joint metal/polymer constrained cemented or uncemented prosthesis, 21 CFR 888.3310

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis, 21 CFR 8888 3390

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 21 CFR 8888 3360

Product Codes: 87 LZO, 87 LWJ, 87 JDI, 87 LPH, 87 MEH, 87 KWZ, 87 KWY, and 87 KWL

Contact Information:	Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5467Fax: (201) 831-6038
Date Prepared:	July 27, 2004

Device Description:

{1}------------------------------------------------

K040734
page 2 of 2

and adds a new style of proximal body called the MT3 body for use with the previously cleared distal stem components

Intended Use:

The Restoration® Modular System is intended for for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific stoms are designed to the Restoration® Modular System include, non-inflammatory muroutions for aos of the result including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other arminis, corroction of have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Substantial Equivalence:

The features of the new components are substantially equivalent to the predicate I he reatures of the no no arities in intended use, materials and design. Mechanical ucvices based on similaries in lievivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is facing left and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2004

Ms. Vivian Kelly Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430

Re: K040734
Trade/Device Name:	Restoration Modular System: Addition of the MT3 body;Modification to the 19mm Cone Body
Regulation Number:	21CFR 888.3353; 21CFR 888.3350; 21 CFR 888.3358; 21 CFR 888.3310;21CFR 888.3390; 21CFR 888.3360
Regulation Name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis; Hip joint metal/polymer semi-constrained cemented prosthesis; Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; Hip jointmetal/polymer constrained cemented or uncemented prosthesis; Hip jointfemoral (hemi-hip) metal/polymer cemented or uncemented prosthesis;and Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis
Regulatory Class: II
Product Code: LZO, LWJ, JDI, LPH, KWZ, KWY, KWL, MEH
Dated: August 2, 2004

Dear Ms. Kelly:

Received: August 4, 2004

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.

{3}------------------------------------------------

Page 2 - Ms. Vivian Kelly

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.

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 (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 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 vours

Sincerely yours,

Mark M. Millman

Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K040734

Device Name: Restoration® Modular System

Indications For Use:

. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, and �
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evantation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

4040734

510(k) Number K0407

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.