C-Stem AMT LE Prosthesis
Device Facts
| Record ID | K220216 |
|---|---|
| Device Name | C-Stem AMT LE Prosthesis |
| Applicant | Depuy Ireland UC |
| Product Code | JDI · Orthopedic |
| Decision Date | Jul 22, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Total hip arthroplasty
Device Story
C-Stem AMT LE Hip Prosthesis is a collarless, triple-tapered, cemented femoral stem for total hip arthroplasty. Device is manufactured from wrought stainless steel (ISO 5832-9/Ortron-90) and features a polished surface. It is used with modular femoral heads (metal or ceramic) and compatible with DePuy acetabular shells and liners. Intended for use by orthopedic surgeons in clinical settings. Device provides structural support for hip joint replacement, aiming to reduce pain and restore mobility. It is a line extension of the C-Stem AMT system, sharing identical materials and core design features like the 12/14 Articul/EZE Mini Taper and raised lateral shoulder. Surgeons select appropriate stem sizes and offsets based on patient anatomy to ensure stable fixation within the femoral canal using bone cement.
Clinical Evidence
No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including neck fatigue (ISO 7206-6), distal stem fatigue (ISO 7206-4), range of motion (BS EN ISO 21535), biocompatibility (ISO 10993-1, -5, -18), bacterial endotoxin testing (ANSI/AAMI ST 72), and MRI safety evaluation (ASTM F2503, F2213, F2119, F2182).
Technological Characteristics
Wrought stainless steel (ISO 5832-9/Ortron-90); cemented fixation; polished surface; 12/14 Articul/EZE Mini Taper; triple-tapered geometry; gamma irradiation sterilization (SAL 10^-6); 5-year shelf life. Compatible with modular femoral heads and DePuy acetabular components.
Indications for Use
Indicated for total hip replacement in patients with severely painful and/or disabled joints due to osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous hip surgery (reconstruction, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement); or certain cases of ankylosis. Indicated for cemented use only.
Regulatory Classification
Identification
A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Predicate Devices
Submission Summary (Full Text)
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July 22, 2022
DePuy Ireland UC Sarah Matamisa Regulatory Affairs Specialist Loughbeg, Ringaskiddy Co. Cork, IRELAND
Re: K220216
Trade/Device Name: C-Stem AMT LE Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LZO Dated: June 17, 2022 Received: June 21, 2022
Dear Sarah Matamisa:
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.
for
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K220216
Device Name C-STEM AMT LE Hip Prosthesis
#### Indications for Use (Describe)
#### INDICATIONS
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The C-Stem AMT LE Hip Prosthesis is indicated 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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# 510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy<br>Co. Cork, IRELAND |
| Establishment Registration Number | 3015516266 |
| Name of contact person | Sarah Matamisa |
| e-mail address | smatamis@its.jnj.com and DePuySynthesJointsRegulatoryAffairs@its.jnj.com |
| Alternative contact person | Clare Hill |
| e-mail address | nkeedy@its.jnj.com |
| Work mobile | +44 7824320636 (UK time zone) |
| Date prepared | 19 January 2022 |
| Name of device | |
| Trade or proprietary name | C-Stem AMT LE Hip Prosthesis |
| Common or usual name | Total Hip Joint Replacement Prosthesis |
| Classification name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented<br>Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3350<br>21 CFR 888.3353 |
| Product Code(s) | JDI, LZO |
| Legally marketed device(s) to which equivalence is claimed | Primary predicate:<br>DePuy C-Stem AMT Hip Prosthesis K042959, cleared December 22, 2004<br>Additional predicates:<br>DePuy C-Stem AMT K082239, cleared August 29, 2008<br>DePuy C-STEM System K982918, cleared October 5, 1998 |
| Reason for 510(k) submission | The purpose of this 510K submission is to obtain market clearance for C-Stem AMT<br>LE Hip Prosthesis. |
| Device description | The C-Stem AMT LE Hip Prosthesis is a collarless, triple-tapered, cemented femoral<br>stem designed to be used as one component of a system of prostheses in hip<br>arthroplasty. It is manufactured from wrought stainless steel conforming to ISO 5832-<br>9 (Ortron-90®) and is polished overall. It is designed to be used with commercially |
| | available modular femoral heads, either metal or ceramic. The subject device is<br>compatible with DePuy acetabular shells and liners. |
| | The C-Stem AMT LE Hip Prosthesis is a line extension of the predicate C-Stem AMT<br>Hip Prosthesis cleared under 510(k) numbers K042959 and K082239. |
| | The subject C-Stem AMT LE Hip Prosthesis and the predicate C-Stem AMT Hip<br>Prosthesis are comprised of identical materials and share common design<br>features, including a polished full-length triple tapered intramedullary<br>geometry, 12/14 Articul/EZE Mini Taper and a raised lateral shoulder. |
| Intended use of the device | Total hip arthroplasty |
| Indications for use | Total hip replacement is indicated in the following conditions:<br>1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis, or congenital hip dysplasia.<br>2. Avascular necrosis of the femoral head.<br>3. Acute traumatic fracture of the femoral head or neck.<br>4. Failed previous hip surgery including joint reconstruction, internal fixation,<br>arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip<br>replacement.<br>5. Certain cases of ankylosis.<br><br>The C-Stem AMT LE Hip Prosthesis is indicated for cemented use only. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES | | | | |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Subject Device:<br>C-Stem AMT LE Hip<br>Prosthesis | Predicate Device #1:<br>DePuy C-Stem AMT Hip Prosthesis<br>K042959 | Predicate Device #2:<br>DePuy C-Stem AMT<br>K082239 | Predicate Device #3:<br>DePuy C-Stem System<br>K982918 |
| Intended Use and<br>Indications for Use | Same as predicate #1 | Total Hip Arthroplasty<br>Intended to provide increased patient<br>mobility and reduce pain by replacing the<br>damaged hip joint articulation in patients<br>where there is evidence of sufficient sound<br>bone to seat and support the components.<br>Total hip replacement is indicated in the<br>following conditions:<br>1. A severely painful and/or disabled joint<br>from osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis, or congenital hip<br>dysplasia.<br>2. Avascular necrosis of the femoral head.<br>3. Acute traumatic fracture of the femoral<br>head or neck.<br>4. Failed previous hip surgery including<br>joint reconstruction, internal fixation,<br>arthrodesis, hemiarthroplasty, surface<br>replacement arthroplasty, or total hip<br>replacement.<br>5. Certain cases of ankylosis.<br>The DePuy® C-Stem AMT Hip Stem is<br>indicated for cemented use only. | Total Hip Arthroplasty<br>The DePuy C-Stem AMT is<br>indicated for cemented use in<br>the treatment of:<br>1. A severely painful and/or a<br>severely disabled joint resulting<br>from osteoarthritis, traumatic<br>arthritis, or rheumatoid arthritis.<br>2. Avascular necrosis of the<br>femoral head;<br>3. Acute traumatic failure of the<br>femoral head or neck;<br>4. Failed previous surgery,<br>including joint reconstruction,<br>internal fixation, arthrodesis,<br>hemiarthroplasty, surface<br>replacement arthroplasty, or<br>other total hip replacement; and<br>5. Certain cases of ankylosis. | Total Hip Arthroplasty<br>Indicated for cemented use as the<br>femoral component in total hip<br>arthroplasty for replacing the hip<br>joint of a patient with severely<br>painful and/ or a severely disabled<br>joint resulting from osteoarthritis,<br>traumatic arthritis, or rheumatoid<br>arthritis; avascular necrosis of the<br>femoral head; acute traumatic<br>fracture of the femoral head or neck;<br>failed previously surgery, including<br>joint reconstruction, internal fixation,<br>arthrodesis, hemiarthroplasty, surface<br>replacement arthroplasty, or other<br>total hip replacement; and certain<br>cases of ankylosis. |
| Properties | | | | |
| Material | Same as predicate #1 | Wrought Stainless Steel "Ortron 90®"<br>conforming to ISO 5832-9 | Same as predicate #1 | Same as predicate #1 |
| Fixation | Same as predicate #1 | Cemented | Same as predicate #1 | Same as predicate #1 |
| Design Features | | | | |
| Surface Finish | Same as predicate #1 | Uncoated/ Brightly polished | Same as predicate #1 | Same as predicate #1 |
| Standard Offset Sizes | CDH ("00"), 1A, 2A,<br>3A, 2 Long, 3 Long, 3<br>XL205, 3 XL240 | 2, 3, 4, 5, 6, 7, 8 | 1 | CDH, 1, 2, 3, 4, 5, 6, 7, 8<br>Revision (200mm and 240mm) 4, 6,<br>8 |
| High Offset Sizes | 2 Long, 3 Long | 2, 3, 4, 5, 6, 7, 8 | 1 | 3, 4, 5 |
| Stem length<br>(Smallest size) | 123.8mm | 138.7mm | 132.5mm | 123.8mm |
| Stem Length<br>(Largest Size) | 240mm | 175.4mm | 132.5mm | 273mm |
| Stem Offsets | Standard and High | Standard and High | Standard and High | Standard and High |
| Restriction on femoral<br>head length to be used<br>in combination with<br>device | No greater than +12 | No restriction | No restriction | Head offsets for Predicate #3 are<br>limited to +6 by design. This is<br>approximately equivalent to +12<br>when an Articul/EZE mini taper is<br>used |
| Trunnion Design | Same as predicate #1 | 12/14 Articul/EZE Mini Taper (AMT) | Same as predicate #1 | 9/10 taper |
| Stem Geometry | Same as predicate #1 | Full triple taper | Same as predicate #1 | Standard length: Full triple taper |
| | | | | |
| Packaging<br>Description | | | | |
| Component | Same as predicate #1 | Double Sterile Barrier Pack INNER:<br>Nylon Pouch OUTER: PETG Blister,<br>Tyvek Lid | Same as predicate #1 | Same as predicate #1 |
| Sterility | | | | |
| Sterile Method | Same as predicate #1 | Gamma irradiation | Same as predicate #1 | Same as predicate #1 |
| Sterility Assurance<br>Level | Same as predicate #1 | 10-6 | Same as predicate #1 | Same as predicate #1 |
| Claimed Shelf Life | Same as predicate #1 | 5 years | Same as predicate #1 | Same as predicate #1 |
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The subject C-Stem AMT LE Hip Prosthesis devices C-Stem AMT Hip Prostiesis (KJ42959, K08239) and C-Stem System (K982918), in intended use, indications for use, material, and predicate systems are intended for total hip atthroplasty and have the same indications for use. All devices are wrought stainless steel, uncoated use. The subject and predicate devices are offeed in standard offied and high officet configurations. Method of sterilization, Sterility Assurance Level (SAL), packaging materials and pedicate devices. Trumion design is identical for the subject device and products of the subject devices falls within the range of stem lengths available for predicate #3 (19829) 8)…
