(106 days)
No
The summary describes a mechanical hip implant system and its materials, design, and testing, with no mention of AI or ML.
Yes.
The device is indicated for conditions such as "Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases" and "Failed previous hip surgery," which implies it is used to treat or alleviate these medical conditions.
No
The Z1 Hip System is a hip implant intended for surgical replacement, not for diagnosing conditions.
No
The device description clearly states that the Z1 Hip System consists of physical femoral hip stems made from titanium alloy, which are implanted into the body. This is a hardware device, not software.
Based on the provided information, the Z1 Hip System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Z1 Hip System is for total or hemi hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details a physical implant (femoral hip stems) made of titanium alloy, designed for surgical implantation. This is a medical device used in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Z1 Hip System does not perform any such function. It is a physical implant.
Therefore, the Z1 Hip System is a medical device used for surgical implantation, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, KWZ, KWY, LWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K150862 / K160907 / K210581, K120030
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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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 |
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| 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.