(116 days)
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.
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.
This document is an FDA 510(k) clearance letter for a medical device called the "Z1 Cemented Hip System." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for device performance as typically understood in the context of an AI/software device.
The information provided describes the hip system itself, not an AI or software component. Therefore, the questions about sample size for test/training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance are not applicable to this document. The document discusses mechanical performance testing of a physical implant.
However, I can extract information related to the physical device's "acceptance criteria" and the studies used to prove it meets those criteria based on the provided text.
Here's the breakdown of what's provided, framed as closely as possible to your request, but with the understanding that this is about a physical orthopedic implant, not an AI device:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted, but does not provide specific quantitative acceptance criteria or reported values for the Z1 Cemented Hip System. Instead, it states that "All necessary testing has been performed... to assure substantial equivalence to the predicate device and to demonstrate the subject device performs as intended." This implies that the acceptance criteria are met if the device performs comparably to the predicate or within established safety and efficacy standards for such devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Distal Stem Fatigue (ISO 7206-4) | Engineering Analysis performed to assure substantial equivalence. |
| Proximal Stem Fatigue (ISO 7206-6) | Engineering Analysis performed to assure substantial equivalence. |
| Range of Motion (ISO 21535) | Evaluation performed to assure substantial equivalence. |
| Material/Design Compatibility: | |
| Modular Connection & Corrosion | Engineering Analysis performed to assure substantial equivalence. |
| MR Compatibility | Justification provided via adoption. |
| Sterilization & Biocompatibility: | |
| Steam & Gamma Sterilization | Adoption justification provided (SAL 10-6 implied for gamma). |
| Endotoxin (USP <85>, AAMI ST72) | Testing performed. |
| Biocompatibility (ISO 10993-1, -5) | Testing performed. |
Note: The document states "engineering analysis" or "evaluation" was performed. Specific numerical results or pass/fail thresholds are not detailed in this summary, as is typical for 510(k) summaries which focus on demonstrating equivalence rather than raw data.
2. Sample Size Used for the Test Set and Data Provenance
This document describes pre-market testing of a physical medical device, not a software or AI algorithm. Therefore, the concept of a "test set" in the context of data points is not directly applicable.
- Sample Size: The document mentions that "All testing was performed on worst case implants as dictated by the relevant performance standards." This implies a representative sample of the manufactured device variants (e.g., different sizes, offsets) were tested, focusing on the configurations most likely to fail. Specific numbers of units tested are not provided in this summary.
- Data Provenance: Not applicable in the context of data origin; this refers to the origin of the physical products tested, which would be the manufacturer, Orchard Medical Development, LLC. The testing is described as pre-market, implying prospective testing of newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is a physical device where "ground truth" is established through standardized engineering and material testing methods, not expert consensus on image interpretation or clinical outcomes data.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to expert review processes, which are not relevant for the mechanical and material testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. MRMC studies are used for evaluating the effectiveness of diagnostic tools (often imaging-based AI) on human reader performance. This document is about a hip implant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical hip implant, not an algorithm.
7. The Type of Ground Truth Used
For this physical device, "ground truth" is established by:
- Adherence to recognized industry standards (e.g., ISO 7206-4, ISO 7206-6, ISO 21535, ISO 10993) for mechanical, material, and biocompatibility testing.
- Engineering analyses and calculations demonstrating design robustness.
- Comparison to the performance characteristics of an existing, legally marketed predicate device (K193030 Zimmer, Inc. Avenir Cemented Hip Stem).
8. The Sample Size for the Training Set
Not applicable. There is no AI training set for this physical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI training set for this physical device.
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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 (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
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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, 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 Cemented 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). 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). |
| PrimaryPredicate | K193030Zimmer, Inc. Avenir Cemented Hip Stem |
| ReferenceDevice(s) | K233476Orchard Medical Development Z1 Cementless Hip SystemK120030Biomet 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 usein total or partial (hemi-) hip arthroplasty. The stem is designed for cementedimplantation into the proximal femur and mates with compatible femoralheads and adapters for use in total or partial (hemi-) hip arthroplasty througha 12/14 male taper connection. The stems are manufactured from forgedstainless steel and have a wedge-shaped design, with a proximal-to-distaltaper. Offered in multiple sizes and neck lengths, the stems are available instandard and high 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 Cemented Hip System femoralstems. The Z1 Cemented Hip System is for use only with the Zimmer Biometfemoral heads and adapters, bipolar heads, acetabular shells, acetabularliners, and distal centralizers / positioners identified in the package insert ascompatible components. |
|---|---|
| Indications forUse Statement | Z1 Cemented Hip System is intended for total or partial (hemi-) hiparthroplasty and is indicated for the following conditions:Advanced wear of the joint due to degenerative, post-traumatic orrheumatic 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
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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.
§ 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.