(155 days)
No
The document describes a mechanical implant and associated instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a femoral stem used in hip replacement surgery to treat failed previous hip surgery, which is a therapeutic intervention.
No
This device is a revision implant for hip replacement surgery, designed to treat failed previous hip surgeries. It is a physical medical device intended for therapeutic intervention, not for diagnosing conditions.
No
The device description clearly states it is a physical implant (femoral stem) made of Ti6Al4V alloy, intended for surgical implantation. It also mentions associated physical instruments and sterilization trays.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The DePuy RECLAIM Monobloc Revision Femoral Stem is a physical implant designed to be surgically inserted into the hip joint to replace a failed previous hip surgery. It is a mechanical device, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use is for the treatment of failed hip surgery, which is a surgical intervention, not a diagnostic process.
The information provided clearly describes a surgical implant and associated instruments, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
Product codes
LZO
Device Description
The Subject Devices DePuy Reclaim Monobloc Femoral Stems are revision implants that are intended to treat patients with prior failed hip replacement devices. They are made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity and in contact with the cortical bone in the canal in an uncemented use.
The design of the Subject Device extramedullary region is based on that of the Predicate Reclaim Modular stem implants which were cleared by the FDA via K102080 in 2010. The extramedullary region has standard and high offset options on a polished neck, with a 12/14 AMT trunnion. The Subject Devices are intended to be inserted into the femoral canal using the Reclaim Monobloc Inserter Instruments.
With the exception of the Subject Device being a one-piece implant versus the Predicate two-piece modular implant, resulting in fewer theoretically possible construct lengths, and the addition of the secondary splines, the Subject and Predicate Devices are identical in intended use, indications for use, materials, sterilization method, and fixation method. The non-modular design, and the addition of the secondary splines do not impact the safety or effectiveness of the Subject Device as compared to the Predicate.
This 510(k) also includes sterilization instrument trays, that, according to FDA guidance document "Medical Device Accessories – Describing Accessories and Classification Pathways, Guidance for Industry and Food and Drug Administration Staff," issued on December 20, 2017, requires clearance under the same product codes as the Subject Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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
The following tests were performed on the Subject Devices, Reclaim Monobloc Revision Femoral Stems, to demonstrate substantial equivalence of safety and effectiveness as compared to the Predicate Device: Stem Fatigue Design Verification (ISO 7206-4) - Pass, Neck Fatigue Design Verification (ISO 7206-6) - Pass, Range of Motion (ISO 21535:2007 Annex A) - Pass, Trays Drop and Mating Part Test - Pass. Biocompatibility tests performed were Monobloc Stem Biocompatibility Testing - Pass, and Instrument Trays Biocompatibility Evaluation - Pass. All testing was performed on final sterile devices. No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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October 21, 2022
DePuy Ireland UC Jennifer Hill Regulatory Project Leader, Regulatory Affairs Loughbeg, Ringaskiddy Co. Cork Munster, P43 ED82, IRELAND
Re: K221462
Trade/Device Name: DePuy Reclaim Monobloc Revision Femoral Stem 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 Dated: July 21, 2022 Received: July 25, 2022
Dear Jennifer Hill:
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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221462
Device Name
DePuy Reclaim Monobloc Revision Femoral Stem
Indications for Use (Describe)
The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
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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510(K) SUMMARY
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, P43 ED82, | |
| IRELAND | |
| Phone number | (+44)7834974433 |
| Fax number | N/A |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Jennifer Hill |
| Date prepared | 20 October 2022 |
| Name of device | |
| Trade or proprietary | |
| name | DePuy Reclaim Monobloc Revision Femoral Stem |
| Common or usual name | Hip Stem Prosthesis |
| Classification name | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained |
| cemented or nonporous uncemented prosthesis. (LZO) | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353 |
| Product Code(s) | LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, |
| Cemented Or Non-Porous, Uncemented. | |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed | DePuy Reclaim Modular (K102080) |
| Reason for 510(k) | |
| submission | The purpose of this submission is for the addition of a new femoral |
| stem option to the DePuy Hip Revision portfolio. | |
| Device description | The Subject Devices DePuy Reclaim Monobloc Femoral Stems are |
| revision implants that are intended to treat patients with prior failed hip | |
| replacement devices. They are made of Ti6Al4V alloy and present a | |
| grit-blasted tapered fluted intramedullary region with splines that are | |
| intended to be in interference of the previously reamed femoral cavity | |
| and in contact with the cortical bone in the canal in an uncemented use. | |
| The design of the Subject Device extramedullary region is based on that | |
| of the Predicate Reclaim Modular stem implants which were cleared by | |
| the FDA via K102080 in 2010. The extramedullary region has standard | |
| and high offset options on a polished neck, with a 12/14 AMT trunnion. | |
| The Subject Devices are intended to be inserted into the femoral canal | |
| using the Reclaim Monobloc Inserter Instruments. | |
| With the exception of the Subject Device being a one-piece implant | |
| versus the Predicate two-piece modular implant, resulting in fewer | |
| theoretically possible construct lengths, and the addition of the | |
| secondary splines, the Subject and Predicate Devices are identical in | |
| intended use, indications for use, materials, sterilization method, and | |
| fixation method. The non-modular design, and the addition of the | |
| secondary splines do not impact the safety or effectiveness of the | |
| Subject Device as compared to the Predicate. | |
| This 510(k) also includes sterilization instrument trays, that, | |
| according to FDA guidance document "Medical Device Accessories | |
| – Describing Accessories and Classification Pathways, Guidance for | |
| Industry and Food and Drug Administration Staff," issued on | |
| December 20, 2017, requires clearance under the same product codes | |
| as the Subject Device. | |
| Intended use of the device | Total Hip Arthroplasty |
| Total hip arthroplasty is intended to provide increased patient mobility | |
| and reduce pain by replacing the damaged hip joint articulation in | |
| patients where there is evidence of sufficient sound bone to seat and | |
| support the components. | |
| Indications for use | The DePuy RECLAIM Monobloc Revision Femoral Stem is |
| indicated for cementless use in the treatment of failed previous hip | |
| surgery, including joint reconstruction, internal fixation, arthrodesis, | |
| hemiarthroplasty, surface replacement arthroplasty, or other total hip | |
| replacement. |
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5
The Subject Device, DePuy Reclaim Monobloc Revision Femoral Stem is substantially equivalent to the Predicate Device, DePuy Reclaim Modular Revision Hip System (K102080) in intended use, design, material, and fixation. The Subject and Predicate Devices are intended for total hip arthroplasty, are made of the Same TigAl/V titanium alloy, are intended for uncement a gri-blasted tapered fluted intramedullary region with splines that are intenterence of the previously reamed femoral cavity and contacting the cortical bone in the canal.
Differences include the type of modularity and number of splines — the Subject Device is a non-modular, singular stem, whereas the Predicate Device is a modular, two-part system. The Subject Device also has additional splines with a taper profile along the stem length which provide greater axial stability. The modification from a modular to singular monobloc device and addition of tapered splines has shown to have no impact on the safety or effectiveness of the Subject Device compared to the Predicate Device.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the Subject Devices, Reclaim Monobloc Revision Femoral Stems, to demonstrate substantial equivalence of safety and effectiveness as compared to the Predicate Device. All testing was performed on final sterile devices:
| Performance Bench Test Results | |
|---|---|
| Test | Conclusion |
| Stem Fatigue Design Verification (ISO 7206-4) | Pass |
| Neck Fatigue Design Verification (ISO 7206-6) | Pass |
| Range of Motion (ISO 21535:2007 Annex A) | Pass |
| Trays Drop and Mating Part Test | Pass |
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| Biocompatibility Results | |
|---|---|
| Test | Conclusion |
| Monobloc Stem Biocompatibility Testing | Pass |
| Instrument Trays Biocompatibility Evaluation | Pass |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical studies were performed for performance testing as appropriate verification of the Subject Device was achieved based on the comparison to the Predicate Device and from the results of the Bench testing and Biocompatibility testing.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
With the exception of the Subject Device a one-piece implant versus the Predicate two-piece modular implant, resulting in fewer theoretically possible construct lengths, and the secondary splines, the Subject and Predicate Devices are identical in intended use, indications for use, materials, sterilization method. The non-modular design, and the addition of the secondary splines do not impact the safety or effectiveness of the Subject Device as compared to the Predicate.