Who is the manufacturer of Z1 Hip System?

Orchard Medical Development filed the 510(k) submission for Z1 Hip System (K233476).

What is the FDA product code for Z1 Hip System?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Z1 Hip System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Z1 Hip System?

Zimmer, Inc. Avenir Complete Hip System (K182048 / K192189).

Who can help prepare an FDA 510(k) submission like Z1 Hip System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Z1 Hip System

K233476 · Orchard Medical Development · LZO · Feb 8, 2024 · Orthopedic

Device Facts

Record ID	K233476
Device Name	Z1 Hip System
Applicant	Orchard Medical Development
Product Code	LZO · Orthopedic
Decision Date	Feb 8, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Z1 Hip System is intended for total or 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, hemiarthroplasty or total hip replacement (THR). - Acute traumatic fracture of the femoral head or neck. - Avascular necrosis of the femoral head. Z1 Hip System is for cementless use only.

Device Story

Z1 Hip System consists of femoral hip stems for total or hemi hip arthroplasty; designed for cementless press-fit implantation into proximal femur; mates with compatible femoral heads/adapters via 12/14 male taper connection. Used in clinical settings by orthopedic surgeons. Stems feature wedge-shaped design; forged Ti-6Al-4V titanium alloy; grit-blasted surface with Ti-6Al-4V plasma coating and hydroxyapatite (HA) overcoat. Available in multiple sizes, offsets (Standard, High Offset, Coxa Vara), and configurations (collared/collarless) to accommodate patient anatomy. System-specific instrumentation prepares femur. Provides stable prosthetic foundation for hip joint; restores joint function; alleviates pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Evaluations included distal fatigue (ISO 7206-4), proximal fatigue (ISO 7206-6), range of motion (ISO 21535), coating characterization (ISO 13779, ISO 2360, ASTM F1926, F1147, F1044, F1854, F1160, F1978, ISO 13179-1), modular connection/corrosion performance, MR compatibility (ASTM F2213, F2182, F2119), sterilization (ISO 11137-2, ISO 17665-1), endotoxin (AAMI ST72), and biocompatibility (ISO 10993-1, ISO 10993-5).

Technological Characteristics

Material: Forged Ti-6Al-4V titanium alloy with Ti-6Al-4V plasma coating and hydroxyapatite (HA) overcoat. Fixation: Cementless press-fit. Design: Wedge-shaped, proximal-to-distal taper, 12/14 male taper connection. Sterilization: Gamma radiation (implant), Steam (instruments). Standards: ISO 7206-4/6, ISO 13779, ASTM F1926, F1147, F1044, F1854, F1160, F1978, ISO 13179-1, ISO 11137-2, ISO 17665-1, AAMI ST72, ISO 10993-1/5, ASTM F2213, F2182, F2119.

Indications for Use

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

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 Complete Hip System (K182048 / K192189)

Reference Devices

DePuy Orthopaedics, Inc. Actis DuoFix Hip Prosthesis (K150862 / K160907 / K210581)
Biomet Manufacturing Corp. Taperloc® Complete Size 4mm and XR 123 (K120030)

Related Devices

K251906 — Z1 Hip System · Zimmer, Inc. · Jul 18, 2025
K182048 — Avenir Complete Hip System · Zimmer, Inc. · Dec 7, 2018
K192189 — Avenir Complete Hip System, Size 0 Coxa Vara · Zimmer, Inc. · Dec 18, 2019
K241241 — Z1 Cemented Hip System · Orchard Medical Development, LLC · Aug 27, 2024
K153381 — Corin Metafix Hip Stem · Corin U.S.A. Limited · Jan 21, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. February 8, 2024 Orchard Medical Development % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evalutations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188 Re: K233476 Trade/Device Name: Z1 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, KWY, KWZ, LWJ, MEH Dated: January 5, 2024 Received: January 5, 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. {1}------------------------------------------------ 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. 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Limin Sun -S Limin Sun, PhD 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K233476 Device Name Z1 Hip System Indications for Use (Describe) Z1 Hip System is intended for total or 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, hemiarthroplasty or total hip replacement (THR). - · Acute traumatic fracture of the femoral head or neck. - · Avascular necrosis of the femoral head. Z1 Hip System is for cementless use only. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## K233476 # | Date Prepared | February 7, 2024 | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor | Orchard Medical Development, LLC 9450 W. Bryn Mawr Ave, Suite 200 Rosemont, IL 60018 (847) 999-0600 | | 510(k) Contact | Secure BioMed Evaluations Justin Gracyalny, MSE Linda Braddon, Ph.D. 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com | | Trade Name | Z1 Hip System | | Common Name | Hip Prosthesis | | Product Code – Device – Regulation Number | LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (21 CFR §888.3353). 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 Predicate | K182048 / K192189 Zimmer, Inc. Avenir Complete Hip System | | Reference Device(s) | K150862 / K160907 / K210581 DePuy Orthopaedics, Inc. Actis DuoFix Hip Prosthesis K120030 Biomet Manufacturing Corp. Taperloc® Complete Size 4mm and XR 123 | {5}------------------------------------------------ | Device Description | Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region, the entire surface of the stem is grit- blasted and sprayed with a Ti-6Al-4V titanium alloy plasma coating followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in Standard, High Offset, and Coxa Vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The Z1 Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, and acetabular shells and liners identified in the package insert as compatible components. | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use Statement | Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions: Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). Acute traumatic fracture of the femoral head or neck. Avascular necrosis of the femoral head. Z1 Hip System is for cementless use only. | ### Comparison of Technological Characteristics | Device Characteristic | Subject Device Orchard Medical Z1 Hip Stem | Primary Predicate Device Zimmer, Inc. Avenir Complete Hip System K182048 / K192189 | |--------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Intended Use | Total Hip Arthroplasty, Hemi-Hip Arthroplasty | Total Hip Arthroplasty, Hemi-Hip Arthroplasty | | Material | Ti-6Al-4V Titanium Alloy with Ti-6Al-4V plasma coating and hydroxyapatite overcoat | Ti-6Al-4V Titanium Alloy with porous CP-Ti coating and hydroxyapatite overcoat | | Fixation Method | Cementless press-fit fixation. | Cementless press-fit fixation. | | Stem Size | 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 0, 1, 2, 3, 4, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | | Collar | Collared, Collarless | Collared, Collarless | {6}------------------------------------------------ | Device Characteristic | Subject Device Orchard Medical Z1 Hip Stem | Primary Predicate Device Zimmer, Inc. Avenir Complete Hip System K182048 / K192189 | |--------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------| | | | | | | | High Offset Coxa Vara | | | Sterilization | Implant: Gamma, SAL 10-6 Instruments: Steam, SAL 10-6 | | Packaging | Dual PETG / Tyvek blister | Dual PETG / Tyvek blister | | Single Use Only | Yes | Yes | | Prescription Use Only | Yes | Yes | ### Technological Characteristics There are no significant technological differences between the subject and predicate device. The subject device uses similar materials, is a similar design, and achieves its intended use in an identical manner as the predicate and both devices are manufactured using subtractive techniques. Minor differences in stem geometry and sizing 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 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 or test coupons as dictated by the relevant performance standards. The following evaluations were conducted: - Distal Fatigue Testing per ISO 7206-4 - Proximal Fatigue Testing per ISO 7206-6 - Range of Motion Evaluation per ISO 21535 ● - . HA and Ti-6Al-4V Coating Characterization per ISO 13779, ISO 2360, ASTM F1926, ASTM F1147, ASTM F1044, ASTM F1854, ASTM F1160, ASTM F1978, ISO 13179-1 - Modular Connection and Corrosion Performance Rationale ● - . MR Compatibility per ASTM F2213, ASTM F2182, ASTM F2119, and RF Heating Modeling - Sterilization per ISO 11137-2, ISO 17665-1 ● - Endotoxin per AAMI ST72 ● - . Biocompatibility per ISO 10993-1, ISO 10993-5 {7}------------------------------------------------ ### 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.