Provident II Hip Stem

K190276 · Stelkast, Inc. · LPH · Mar 8, 2019 · Orthopedic

Device Facts

• Record ID: K190276
• Device Name: Provident II Hip Stem
• Applicant: Stelkast, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 8, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis , and avascular necrosis. 2. Rheumatoid Arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications

Device Story

Provident II Hip Stem is a line extension of the existing Provident Hip Stem system; features shortened stem design. Intended for use in total hip arthroplasty; implanted by orthopedic surgeons in clinical settings. Device serves as femoral component in hip joint replacement; provides structural support and articulation interface. Benefits patients by restoring joint function and mobility in cases of degenerative disease, fracture, or revision. Device is a passive orthopedic implant; no electronic or software components.

Clinical Evidence

Bench testing only. Engineering analysis performed to compare modified stem to predicate. LAL testing performed to confirm compliance with pyrogen limit specifications.

Technological Characteristics

Hip joint prosthesis; femoral stem component. Materials, design, and fixation methods are consistent with predicate Provident Hip Stem line. Intended for both cemented and uncemented applications.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) requiring hip arthroplasty, including revision of failed total hip arthroplasty.

Regulatory Classification

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.

Predicate Devices

• Provident Hip Stem (K935484)
• Provident Hip Stem (K946371)
• Provident Hip Stem (K001745)
• Provident Hip Stem (K002796)
• Provident Hip Stem (K094035)
• Provident Hip Stem (K122773)

Submission Summary (Full Text)

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March 8, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services - USA. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

StelKast, Inc. % Hollace Rhodes Senior Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20005

Re: K190276

Trade/Device Name: Provident II Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LWJ, LZO, OOH, OOI, KWY Dated: February 7, 2019 Received: February 8, 2019

Dear Hollace Rhodes:

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Daniel S. Ramsey -S 2019.03.08 16:29:51 -05'00'

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

### 510(k) Number (if known)

K190276

#### Device Name

Provident II Hip Stem

#### Indications for Use (Describe)

- 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis , and avascular necrosis.
- 2. Rheumatoid Arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

7 Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

| Manufacturer: | StelKast, Inc. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 200 Hidden Valley Road |
| | McMurray, PA 15317 |
| | Phone: [phone] |
| Contact: | Mr. David Stumpo |
| | Vice President of Operations |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| | 1050 K Street NW, Suite 1000 |
| | Washington, DC 20001 |
| | Phone: [phone] |
| Date Prepared: | March 5, 2019 |
| Device Trade Name: | Provident II Hip Stems |
| Device Common Name: | Hip Prosthesis |
| Classification: | 21 CFR 888.3358: Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented prosthesis – Class II<br>21 CFR 888.3350: Hip joint metal/polymer semi-constrained<br>cemented prosthesis – Class II<br>21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented prosthesis – Class II<br>21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented<br>or uncemented prosthesis – Class II<br>21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer<br>cemented or uncemented prosthesis – Class II |

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| Indications for Use: | 1. Non-inflammatory degenerative joint disease including<br>osteoarthritis, traumatic arthritis, and avascular necrosis.<br>2. Rheumatoid Arthritis.<br>3. Correction of functional deformity.<br>4. Treatment of non-union, femoral neck fracture, and trochanteric<br>fractures of the proximal femur with head involvement,<br>unmanageable using other techniques.<br>5. Revision of previously failed total hip arthroplasty.<br>Cemented and Uncemented Applications |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The purpose of this Special 510(k) is to expand the Provident Hip<br>System with a line extension to the existing Provident Hip Stems.<br>The new stems are to be marketed as the Provident II Hip Stems and<br>feature a shortened stem. |
| Predicate Devices: | The Provident II Hip Stems are substantially equivalent to the<br>predicate stems of the Provident Hip Stem line (K935484,<br>K946371, K001745, K002796, K094035, K122773), with respect<br>to intended use, materials, design, range of available sizes, method<br>of fixation, and performance characteristics. The information<br>summarized in the Design Control Activities Summary<br>demonstrates that the modified stem length of the Provident II Hip<br>Stem meets the pre-determined acceptance criteria for the<br>verification activities. |
| Substantial<br>Equivalence: | An engineering analysis was performed on both the modified and<br>predicate stems. All results demonstrate that the modified device<br>performs similarly to the predicate device.<br>Limulus Amebocyte Lysate (LAL) testing has been performed to<br>establish that the device meets pyrogen limit specifications. |