Restoration Modular 115mm Conical Distal Stem

K213129 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · LZO · Dec 21, 2021 · Orthopedic

Device Facts

• Record ID: K213129
• Device Name: Restoration Modular 115mm Conical Distal Stem
• Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
• Product Code: LZO · Orthopedic
• Decision Date: Dec 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The subject Restoration Modular 115mm Conical Distal Stem is a sterile, single-use device intended for use in total hip arthroplasty.

Device Story

The Restoration Modular 115mm Conical Distal Stem is a component of the Restoration Modular Hip System, a modular femoral replacement system. It is a sterile, single-use, straight, conical, fluted distal stem designed for press-fit fixation into a prepared femoral canal. The device is used by orthopedic surgeons in clinical settings during primary or revision total hip arthroplasty. It features a male locking taper that mates with compatible Restoration Modular Proximal Femoral Bodies and a Locking Bolt. By allowing independent sizing of the proximal body and distal stem, the system enables surgeons to adjust hip biomechanics, including anteversion, height, and offset. The device provides structural stability and fixation for the femoral component, helping to restore joint function and alleviate pain associated with degenerative or traumatic hip conditions. It is labeled as MR Conditional.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence is supported by non-clinical laboratory testing, including distal stem fatigue testing (ISO 7206-4), biocompatibility (ISO 10993-1), shelf-life validation, and MR compatibility testing (ASTM F2052, F2213, F2182, F2119).

Technological Characteristics

Material: Ti-6Al-4V ELI alloy (ASTM F136). Design: Straight, conical, fluted stem with male locking taper. Dimensions: 115mm length, 12mm-23mm diameters. Surface treatment: Shot peened and grit blasted. Fixation: Press-fit (cementless). MR Conditional. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed previous treatments, or nonunions/fractures of the proximal femur. Used in primary and revision total hip arthroplasty, including cases of severe proximal bone loss. Designed for press-fit fixation in the proximal femur.

Regulatory Classification

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.

Predicate Devices

• Restoration Modular Conical Distal Stem (K013106, K022549, K121308)

Submission Summary (Full Text)

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December 21, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Howmedica Osteonics Corp., dba Stryker Orthopaedics Allison Byrne Senior Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K213129

Trade/Device Name: Restoration Modular 115mm Conical Distal Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, LPH, MEH, KWZ, JDI, MAY, MBL Dated: September 23, 2021 Received: September 27, 2021

Dear Allison Byrne:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K213129

#### Device Name

Restoration Modular 115mm Conical Distal Stem

Indications for Use (Describe)

- · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
· Rheumatoid arthritis;

- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and,
- · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Primary and 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Sponsor | Howmedica Osteonics Corp. d/b/a Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allison Byrne<br>Senior Specialist, Regulatory Affairs<br>Stryker Orthopaedics<br>[e-mail]<br>Ph: 201-831-5969 |
| Alternate Contact: | Krutanjali Shah<br>Senior Manager, Regulatory Affairs<br>Stryker Orthopaedics<br>[e-mail]<br>Ph: 201-831-5665 |
| Date Prepared: | September 23rd, 2021 |
| Proprietary Name: | Restoration Modular 115mm Conical Distal Stem |
| Common Name: | Total Hip Joint Replacement |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (21 CFR § 888.3353)<br>Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis (21 CFR § 888.3358)<br>Hip joint metal/polymer constrained cemented or uncemented<br>prosthesis (21 CFR § 888.3310)<br>Hip joint metal/polymer semi-constrained cemented prosthesis (21<br>CFR § 888.3350) |
| Product Codes: | LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer,<br>cemented or non-porous, uncemented<br>LPH - prosthesis, hip, semi-constrained, metal/polymer, porous<br>uncemented<br>MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer,<br>non-porous, calcium-phosphate<br>KWZ - prosthesis, hip, constrained, cemented or uncemented,<br>metal/polymer<br>JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented<br>MAY - prosthesis, hip, semi-constrained, metal/ceramic/polymer,<br>cemented or non-porous cemented, osteophilic finish |

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MBL - prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

#### Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:

- Restoration Modular Conical Distal Stem (K013106, K022549, K121308) ●
### Reason for 510(k) Submission:

The purpose of this submission is to introduce a line extension to the Restoration® Modular Hip System, specifically a new straight, conical distal stem.

### Device Description:

The subject Restoration Modular 115mm Conical Distal Stem is a line extension to the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.

The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.

#### Intended Use:

The subject Restoration Modular 115mm Conical Distal Stem is a sterile, single-use device intended for use in total hip arthroplasty.

#### Indications for Use:

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

## Summary of Technological Characteristics:

The Restoration Modular Conical Distal Stem is a sterile, single-use device that is intended to be press-fit into a prepared proximal femur for cementless fixation in either primary or revision total hip arthroplasty. The predicate device is the straight Restoration Modular Conical Distal Stem, herein referred to as the predicate Restoration Modular Conical Distal Stem. The predicate

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Restoration Modular Conical Distal Stem is currently available in 2 lengths, 155mm or 195mm, each available in 15 diameters ranging from 14mm to 28mm (in increments of 1mm). The subject device introduces an additional straight conical distal stem component into the currently marketed Restoration Modular Hip System. The subject device is herein referred to as the Restoration Modular 115mm Conical Distal Stem and is available in 12 diameters ranging from 12mm to 23mm (in increments of 1mm).

The predicate Restoration Modular Conical Distal Stem and the subject Restoration Modular 115mm Conical Distal Stem are both straight, conical, fluted components with a taper extending the length of the stem, leading to a diametrically larger proximal section and smaller distal section. Both stems are machined from Ti-6A1-4V ELI alloy per ASTM F136 that is shot peened and then grit blasted after machining. They share an identical male locking taper that mates with the currently marketed compatible cone and calcar proximal femoral bodies.

#### Non-Clinical Performance Data:

The following non-clinical laboratory testing and engineering analyses were conducted to determine substantial equivalence:

- Distal Stem Fatigue Testing per ISO 7206-4:2010/AMD 1:2016 ●
- Biocompatibility evaluated per ISO 10993-1:2018 ●
- Biocompatibility of the device packaging evaluated per ASTM F2475-20
- Shelf-life validated per the following standards: ●
- ISO 11607-1:2019 O
- o ISO 11607-2:2019
- ASTM F1980-16 O
- Testing performed per the following methods: O
- ASTM F1886/F1886M-16 ■
- ASTM F1929-15
- ASTM F88/88M-15
- l ASTM F2096-11(2019)
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2019 was used for . pyrogenicity testing to achieve an endotoxin limit of < 20EU/Device.

The subject Restoration Modular 115mm Conical Distal Stem has been submitted as MR Conditional. In alignment with FDA guidance document titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," dated May 20, 2021, evaluations were performed according to the standards listed below:

- Magnetically Induced Displacement Force performed per ASTM F2052-15
- Magnetically Induced Torque performed per ASTM F2213-17 ●
- Heating by RF Fields performed per ASTM F2182-19 ●
- . Image Artifact performed per ASTM F2119-07 (2013)

#### Clinical Testing:

Clinical testing was not required as a basis to support substantial equivalence.

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## Conclusion:

Based upon an evaluation of intended use, indications for use, technological characteristics, principles of operation, and non-clinical performance data, the subject Restoration Modular 115mm Conical Distal Stem is substantially equivalent to the predicate Restoration Modular Conical Distal Stem.