Z1 Cemented Hip System

K241241 · Orchard Medical Development, LLC · LZO · Aug 27, 2024 · Orthopedic

Device Facts

• Record ID: K241241
• Device Name: Z1 Cemented Hip System
• Applicant: Orchard Medical Development, LLC
• Product Code: LZO · Orthopedic
• Decision Date: Aug 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Z1 Cemented Hip System is intended for total or partial (hemi-) hip arthroplasty and is indicated for the following conditions: Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR). Acute traumatic fracture of the femoral head or neck. Avascular necrosis of the femoral head. Z1 Cemented Hip System consists of implants that are for cemented use only.

Device Story

Z1 Cemented Hip System comprises forged stainless steel femoral stems for cemented implantation into proximal femur; used in total or partial (hemi-) hip arthroplasty. Device mates with compatible femoral heads/adapters via 12/14 male taper. Available in multiple sizes, neck lengths, offsets, and collared/collarless configurations to accommodate patient anatomy. Used in clinical/OR settings by orthopedic surgeons. System-specific instrumentation prepares femur. Output is mechanical hip joint reconstruction; benefits patient by restoring joint function and mobility. Device is single-use and provided sterile.

Clinical Evidence

Bench testing only. Evaluations included distal and proximal stem fatigue (ISO 7206-4, ISO 7206-6), range of motion (ISO 21535), modular connection/corrosion analysis, MR compatibility, sterilization validation, endotoxin testing (USP <85>, AAMI ST72), and biocompatibility (ISO 10993-1, ISO 10993-5).

Technological Characteristics

Forged stainless steel femoral stems; wedge-shaped design with proximal-to-distal taper. 12/14 male taper connection. Sterile, single-use, gamma-irradiated (SAL 10-9). Compatible with specific Zimmer Biomet femoral heads, adapters, bipolar heads, acetabular shells/liners, and distal centralizers.

Indications for Use

Indicated for patients requiring total or partial (hemi-) hip arthroplasty due to degenerative, post-traumatic, or rheumatic joint wear; failed prior hip surgery (osteotomy, arthrodesis, hemi-arthroplasty, or THR); acute traumatic femoral head/neck fracture; or avascular necrosis of the femoral head.

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

• Zimmer, Inc. Avenir Cemented Hip Stem (K193030)

Reference Devices

• Orchard Medical Development Z1 Cementless Hip System (K233476)
• Biomet Manufacturing Corp. Taperloc® Complete Size 4mm and XR 123 (K120030)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

August 27, 2024

Orchard Medical Development, LLC % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, Georgia 30188

Re: K241241

Trade/Device Name: Z1 Cemented Hip System 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, KWL, MEH, KWZ, KWY, LWJ Dated: July 30, 2024 Received: July 30, 2024

Dear Justin Gracyalny:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-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,

# Limin Sun -S

Limin Sun, Ph.D. 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) K241241

Device Name Z1 Cemented Hip System

Indications for Use (Describe)

Z1 Cemented Hip System is intended for total or partial (hemi-) hip arthroplasty and is indicated for the following conditions:

- · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
· Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR).

· Acute traumatic fracture of the femoral head or neck.

· Avascular necrosis of the femoral head.

Z1 Cemented Hip System consists of implants that are for cemented use only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K241241 510(k) SUMMARY:

Orchard Medical Development, LLC Z1 Cemented Hip System

| Date Prepared | August 27, 2024 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Orchard Medical Development, LLC<br>9450 W. Bryn Mawr Ave, Suite 200<br>Rosemont, IL 60018<br>[phone] |
| 510(k) Contact | Secure BioMed Evaluations<br>Justin Gracyalny, MSE<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway, Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>[e-mail] |
| Trade Name | Z1 Cemented Hip System |
| Common Name | Hip Prosthesis |
| Product Code –<br>Device –<br>Regulation<br>Number | LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (21 CFR §888.3353). KWL – Prosthesis, Hip, Hemi-, Femoral, Metal (21 CFR §888.3360) MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium Phosphate (21 CFR §888.3353). KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (21 CFR §888.3310). KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (21 CFR §888.3390). LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (21 CFR §888.3360). |
| Primary<br>Predicate | K193030<br>Zimmer, Inc. Avenir Cemented Hip Stem |
| Reference<br>Device(s) | K233476<br>Orchard Medical Development Z1 Cementless Hip System<br>K120030<br>Biomet Manufacturing Corp. Taperloc® Complete Size 4mm and XR 123 |

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| Device Description | The Z1 Cemented Hip System consists of femoral hip stems intended for use<br>in total or partial (hemi-) hip arthroplasty. The stem is designed for cemented<br>implantation into the proximal femur and mates with compatible femoral<br>heads and adapters for use in total or partial (hemi-) hip arthroplasty through<br>a 12/14 male taper connection. The stems are manufactured from forged<br>stainless steel and have a wedge-shaped design, with a proximal-to-distal<br>taper. Offered in multiple sizes and neck lengths, the stems are available in<br>standard and high offsets and as collared or collarless stems in each offset to<br>accommodate various patient anatomies. The hip stems are provided sterile<br>and are for single use only. System-specific instrumentation is available to<br>prepare the femur for implantation of the Z1 Cemented Hip System femoral<br>stems. The Z1 Cemented Hip System is for use only with the Zimmer Biomet<br>femoral heads and adapters, bipolar heads, acetabular shells, acetabular<br>liners, and distal centralizers / positioners identified in the package insert as<br>compatible components. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use Statement | Z1 Cemented Hip System is intended for total or partial (hemi-) hip<br>arthroplasty and is indicated for the following conditions:<br>Advanced wear of the joint due to degenerative, post-traumatic or<br>rheumatic diseases. Failed previous hip surgery including joint reconstruction<br>(osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement<br>(THR). Acute traumatic fracture of the femoral head or neck. Avascular necrosis of the femoral head. Z1 Cemented Hip System consists of implants that are for cemented use only. |

## Technological Characteristics

The subject and predicate device similar design characteristics. Both devices are stainless steel implants intended for use in total and partial (hemi-) hip arthroplasty with bone cement. Both devices are of a similar design and achieve their intended use in an identical manner. Both devices are offered in similar sizes and design configurations. Both devices are single use, prescription use only and provide sterile via gamma irradiation (SAL 10-9) to the end user.

There are no significant technological differences between the subject and predicate device. Minor differences in stem geometry and sizing nomenclature are addressed via performance testing and similarity to the reference device.

## Non-Clinical Performance Testing Summary

All necessary testing has been performed for the Z1 Cemented Hip System to assure substantial equivalence to the predicate device and to demonstrate the subject device performs as intended. All testing was performed on worst case implants as dictated by the relevant performance

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standards. The following evaluations were conducted or leveraged from previous submissions via supporting justifications:

- Distal Stem Fatigue Performance Engineering Analysis (ISO 7206-4) ●
- Proximal Stem Fatigue Performance Engineering Analysis (ISO 7206-6) ●
- Range of Motion Evaluation (ISO 21535) ●
- Modular Connection and Corrosion Performance Engineering Analysis ●
- MR Compatibility Adoption Justification ●
- Steam and Gamma Sterilization Adoption
- Endotoxin per USP <85>, AAMI ST72 ●
- Biocompatibility per ISO 10993-1, ISO 10993-5 .

### Conclusions

Based on the similarities of the intended use/indications for use, technological and functional characteristics, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.