(116 days)
No
The description focuses on the mechanical design, materials, and intended use of a physical hip implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a hip stem intended for use in total or partial hip arthroplasty, which is a surgical procedure to treat conditions like advanced joint wear, failed previous hip surgeries, and fractures, aiming to restore joint function and reduce pain.
No
The Z1 Cemented Hip System is a medical implant (femoral hip stem) used in hip arthroplasty, not a device that diagnoses conditions.
No
The device description clearly states it consists of physical implants (femoral hip stems made of forged stainless steel) and system-specific instrumentation, which are hardware components.
Based on the provided information, the Z1 Cemented Hip System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for total or partial hip arthroplasty, which is a surgical procedure involving the implantation of a medical device into the body to replace a joint. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a femoral hip stem, an implant made of stainless steel, designed for surgical implantation. This is a physical medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue), detect diseases or conditions in vitro, or provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Z1 Cemented Hip System does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWL, MEH, KWZ, KWY, LWJ
Device Description
The Z1 Cemented Hip System consists of femoral hip stems intended for use in total or partial (hemi-) hip arthroplasty. The stem is designed for cemented implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or partial (hemi-) hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from forged stainless steel and have a wedge-shaped design, with a proximal-to-distal taper. Offered in multiple sizes and neck lengths, the stems are available in standard and high 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 Cemented Hip System femoral stems. The Z1 Cemented Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, acetabular shells, acetabular liners, and distal centralizers / positioners 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
Proximal femur, femoral head, femoral neck, hip joint
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 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 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 , 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.
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 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.
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.
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
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)
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
K241241 510(k) SUMMARY:
Orchard Medical Development, LLC Z1 Cemented Hip System
| Date Prepared | August 27, 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 Cemented 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). 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 | |
| Predicate | K193030 |
| Zimmer, Inc. Avenir Cemented Hip Stem | |
| Reference | |
| Device(s) | K233476 |
| Orchard Medical Development Z1 Cementless Hip System | |
| K120030 | |
| Biomet Manufacturing Corp. Taperloc® Complete Size 4mm and XR 123 |
5
| Device Description | The Z1 Cemented Hip System consists of femoral hip stems intended for use
in total or partial (hemi-) hip arthroplasty. The stem is designed for cemented
implantation into the proximal femur and mates with compatible femoral
heads and adapters for use in total or partial (hemi-) hip arthroplasty through
a 12/14 male taper connection. The stems are manufactured from forged
stainless steel and have a wedge-shaped design, with a proximal-to-distal
taper. Offered in multiple sizes and neck lengths, the stems are available in
standard and high 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 Cemented Hip System femoral
stems. The Z1 Cemented Hip System is for use only with the Zimmer Biomet
femoral heads and adapters, bipolar heads, acetabular shells, acetabular
liners, and distal centralizers / positioners identified in the package insert as
compatible components. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use Statement | 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. |
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
6
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 , 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.