(106 days)
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.
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.
This document describes the Z1 Hip System, a medical device for hip arthroplasty. However, the provided text does not contain any information regarding clinical studies with human subjects, acceptance criteria for such studies, or information about AI/algorithm performance. The document is a 510(k) premarket notification to the FDA, focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, I cannot provide details for most of your requested points, as they pertain to clinical trials and AI/algorithm performance, which are not present in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a summary of non-clinical performance testing performed according to various ISO and ASTM standards. The "acceptance criteria" discussed are related to the successful completion of these engineering tests, demonstrating that the device meets the requirements of the standards and is substantially equivalent to the predicate device. The document does not specify quantitative acceptance criteria with reported numerical values for each test in a comparative table format. Instead, it states that "All necessary testing has been performed... to assure substantial equivalence... All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards." and "Based on the similarities of... the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device."
Here's an interpretation based on the non-clinical tests mentioned:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | |
| Conformity to ISO 7206-4 (Distal Fatigue) | Testing performed, demonstrating performance as intended. |
| Conformity to ISO 7206-6 (Proximal Fatigue) | Testing performed, demonstrating performance as intended. |
| Conformity to ISO 21535 (Range of Motion Evaluation) | Testing performed, demonstrating performance as intended. |
| Material/Coating Characterization: | |
| Conformity to ISO 13779, ISO 2360, ASTM F1926, ASTM F1147, | Testing performed for HA and Ti-6Al-4V Coating, demonstrating performance as intended. |
| ASTM F1044, ASTM F1854, ASTM F1160, ASTM F1978, ISO 13179-1 | |
| Modular Connection & Corrosion Performance: | Rationale provided, demonstrating performance as intended. |
| Conformity to relevant standards (implied) | |
| MR Compatibility: | |
| Conformity to ASTM F2213, ASTM F2182, ASTM F2119, and RF Heating Modeling | Testing performed, demonstrating MR compatibility. |
| Sterilization: | |
| Conformity to ISO 11137-2, ISO 17665-1 (SAL 10-6) | Testing performed, demonstrating appropriate sterilization. |
| Endotoxin: | |
| Conformity to AAMI ST72 | Testing performed, demonstrating acceptable endotoxin levels. |
| Biocompatibility: | |
| Conformity to ISO 10993-1, ISO 10993-5 | Testing performed, demonstrating biocompatibility. |
| Overall Substantial Equivalence: | Demonstrated through the entirety of non-clinical performance testing and comparison to predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses non-clinical performance testing (mechanical, material, sterilization, etc.) on implants or test coupons, not clinical data from human subjects. Therefore, the concepts of "test set," "data provenance," "country of origin," "retrospective or prospective," and "sample size" in the context of human data are not applicable here. The document refers to "worst case implants or test coupons" for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes non-clinical engineering and material testing, not human-read clinical data requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no clinical test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC study or AI assistance in this document. The device is a physical hip implant (Z1 Hip System).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the document refers to a physical hip implant and not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is defined by the specifications and requirements of the referenced ISO and ASTM standards (e.g., a specific fatigue load cycle, a particular coating thickness range, sterility assurance level). The device's performance is compared against these engineering and material standards.
8. The sample size for the training set
This is not applicable, as there is no training set mentioned for an algorithm or AI.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set mentioned for an algorithm or AI.
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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.
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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.
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).
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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
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Indications for Use
Submission Number (if known)
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)
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K233476
| Date Prepared | February 7, 2024 |
|---|---|
| Sponsor | Orchard Medical Development, LLC9450 W. Bryn Mawr Ave, Suite 200Rosemont, IL 60018(847) 999-0600 |
| 510(k) Contact | Secure BioMed EvaluationsJustin Gracyalny, MSELinda Braddon, Ph.D.7828 Hickory Flat Highway, Suite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com |
| Trade Name | Z1 Hip System |
| Common Name | Hip Prosthesis |
| Product Code –Device –RegulationNumber | 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). |
| PrimaryPredicate | K182048 / K192189Zimmer, Inc. Avenir Complete Hip System |
| ReferenceDevice(s) | K150862 / K160907 / K210581DePuy Orthopaedics, Inc. Actis DuoFix Hip ProsthesisK120030Biomet Manufacturing Corp. Taperloc® Complete Size 4mm and XR 123 |
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| DeviceDescription | Z1 Hip System consists of femoral hip stems intended for use in total or hemihip arthroplasty. The stem is designed for cementless implantation into theproximal femur and mates with compatible femoral heads and adapters foruse 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 andhave a wedge-shaped design, with a proximal-to-distal taper. Apart from thehighly polished femoral neck region, the entire surface of the stem is grit-blasted and sprayed with a Ti-6Al-4V titanium alloy plasma coatingfollowed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes andneck lengths, the stems are available in Standard, High Offset, and CoxaVara offsets and as collared or collarless stems in each offset toaccommodate various patient anatomies. The hip stems are provided sterileand are for single use only. System-specific instrumentation is available toprepare the femur for implantation of the Z1 Hip System femoral stems. TheZ1 Hip System is for use only with the Zimmer Biomet femoral heads andadapters, bipolar heads, and acetabular shells and liners identified in thepackage insert as compatible components. |
|---|---|
| Indications forUse Statement | Z1 Hip System is intended for total or hemi hip arthroplasty and is indicatedfor the following conditions:Advanced wear of the joint due to degenerative, posttraumatic orrheumatic 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
| DeviceCharacteristic | Subject DeviceOrchard MedicalZ1 Hip Stem | Primary Predicate DeviceZimmer, Inc.Avenir Complete Hip SystemK182048 / 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 |
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| DeviceCharacteristic | Subject DeviceOrchard MedicalZ1 Hip Stem | Primary Predicate DeviceZimmer, Inc.Avenir Complete Hip SystemK182048 / K192189 |
|---|---|---|
| High OffsetCoxa Vara | ||
| Sterilization | Implant: Gamma, SAL 10-6Instruments: Steam, SAL 10-6 | |
| Packaging | Dual PETG / Tyvek blister | Dual PETG / Tyvek blister |
| Single Use Only | Yes | Yes |
| Prescription UseOnly | 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
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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.
§ 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.