(177 days)
No
The document describes a mechanical hip prosthesis and its testing, with no mention of AI or ML capabilities.
Yes
The device, a hip prosthesis, is designed to replace a severely painful and/or disabled joint, fulfilling a therapeutic purpose by alleviating symptoms and restoring function.
No
The C-Stem AMT LE Hip Prosthesis is a femoral stem used in total hip replacement surgery, which is a treatment for conditions like osteoarthritis or hip fractures. It is a prosthetic implant, not a device designed to diagnose medical conditions.
No
The device description clearly states it is a "cemented femoral stem manufactured from wrought stainless steel," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure (total hip replacement) to treat conditions affecting the hip joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a physical implant (femoral stem) designed to be surgically placed in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from 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 including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The C-Stem AMT LE Hip Prosthesis is indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LZO
Device Description
The C-Stem AMT LE Hip Prosthesis is a collarless, triple-tapered, cemented femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. It is manufactured from wrought stainless steel conforming to ISO 5832-9 (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 compatible with DePuy acetabular shells and liners.
The C-Stem AMT LE Hip Prosthesis is a line extension of the predicate C-Stem AMT 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 Prosthesis are comprised of identical materials and share common design features, including a polished full-length triple tapered intramedullary geometry, 12/14 Articul/EZE Mini Taper and a raised lateral shoulder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Testing and engineering analyses were performed on the Prosthesis to demonstrate substantial equivalence of safety and efficacy with the predicate device, addressing:
- Neck Fatigue (to ISO 7206-6: 2013)
- Distal Stem Fatigue (to ISO 7206-4: 2010)
- Range of Motion (to BS EN ISO 21535: 2009)
Biocompatibility evaluation was carried out to ISO 1093-1:2018 and testing was carried out to include cytotoxicity to ISO 1099-5:2009 and chemical characterization to ISO 10993-18:2020.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
Magnetic Resonance Imaging safety evaluation testing was performed following ASTM F2503-13, and the tests evaluated the constructs for magnetically induced force (ASTM F2132-17), image artefact (ASTM F2119-07 (reapproved 2013)) and RF heating (ASTM F2182-19). The testing concluded that there are no safety issues related to magnetic field interactions identified in the labelling.
No clinical tests were conducted to demonstrate substantial equivalence.
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.
Not Found
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
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).(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.
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.
1
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:
-
A severely painful and/or disabled joint from 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 including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
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 |
| 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 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3350 |
| 21 CFR 888.3353 | |
| Product Code(s) | JDI, LZO |
| Legally marketed device(s) to which equivalence is claimed | Primary predicate: |
| DePuy C-Stem AMT Hip Prosthesis K042959, cleared December 22, 2004 | |
| Additional predicates: | |
| DePuy C-Stem AMT K082239, cleared August 29, 2008 | |
| 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 |
| LE Hip Prosthesis. | |
| Device description | The C-Stem AMT LE Hip Prosthesis is a collarless, triple-tapered, cemented femoral |
| stem designed to be used as one component of a system of prostheses in hip | |
| arthroplasty. It is manufactured from wrought stainless steel conforming to ISO 5832- | |
| 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 | |
| compatible with DePuy acetabular shells and liners. | |
| The C-Stem AMT LE Hip Prosthesis is a line extension of the predicate C-Stem AMT | |
| 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 | |
| Prosthesis are comprised of identical materials and share common design | |
| features, including a polished full-length triple tapered intramedullary | |
| 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: |
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
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 including joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip
replacement. - Certain cases of ankylosis.
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: | |||
| C-Stem AMT LE Hip | ||||
| Prosthesis | Predicate Device #1: | |||
| DePuy C-Stem AMT Hip Prosthesis | ||||
| K042959 | Predicate Device #2: | |||
| DePuy C-Stem AMT | ||||
| K082239 | Predicate Device #3: | |||
| DePuy C-Stem System | ||||
| K982918 | ||||
| Intended Use and | ||||
| Indications for Use | Same as predicate #1 | Total Hip Arthroplasty | ||
| 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. | ||||
| Total hip replacement is indicated in the | ||||
| following conditions: |
- A severely painful and/or disabled joint
from osteoarthritis, traumatic arthritis,
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 including
joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface
replacement arthroplasty, or total hip
replacement. - Certain cases of ankylosis.
The DePuy® C-Stem AMT Hip Stem is
indicated for cemented use only. | Total Hip Arthroplasty
The DePuy C-Stem AMT is
indicated for cemented use in
the treatment of: - A severely painful and/or a
severely disabled joint resulting
from osteoarthritis, traumatic
arthritis, or rheumatoid arthritis. - Avascular necrosis of the
femoral head; - Acute traumatic failure of the
femoral head or neck; - Failed previous surgery,
including joint reconstruction,
internal fixation, arthrodesis,
hemiarthroplasty, surface
replacement arthroplasty, or
other total hip replacement; and - Certain cases of ankylosis. | Total Hip Arthroplasty
Indicated for cemented use as the
femoral component in total hip
arthroplasty for replacing the hip
joint of a patient with severely
painful and/ or a severely disabled
joint resulting from osteoarthritis,
traumatic arthritis, or rheumatoid
arthritis; avascular necrosis of the
femoral head; acute traumatic
fracture of the femoral head or neck;
failed previously surgery, including
joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface
replacement arthroplasty, or other
total hip replacement; and certain
cases of ankylosis. |
| Properties | | | | |
| Material | Same as predicate #1 | Wrought Stainless Steel "Ortron 90®"
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,
3A, 2 Long, 3 Long, 3
XL205, 3 XL240 | 2, 3, 4, 5, 6, 7, 8 | 1 | CDH, 1, 2, 3, 4, 5, 6, 7, 8
Revision (200mm and 240mm) 4, 6,
8 |
| High Offset Sizes | 2 Long, 3 Long | 2, 3, 4, 5, 6, 7, 8 | 1 | 3, 4, 5 |
| Stem length
(Smallest size) | 123.8mm | 138.7mm | 132.5mm | 123.8mm |
| Stem Length
(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
head length to be used
in combination with
device | No greater than +12 | No restriction | No restriction | Head offsets for Predicate #3 are
limited to +6 by design. This is
approximately equivalent to +12
when an Articul/EZE mini taper is
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
Description | | | | |
| Component | Same as predicate #1 | Double Sterile Barrier Pack INNER:
Nylon Pouch OUTER: PETG Blister,
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
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),
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Testing and engineering analyses were performed on the Prosthesis to demonstate substantial equivalence of safety and efficacy with the predicate device, addressing:
- Neck Fatigue (to ISO 7206-6: 2013) ●
- Distal Stem Fatigue (to ISO 7206-4: 2010) .
- Range of Motion (to BS EN ISO 21535: 2009) ●
8
Biocompatibility evaluation was carried out to ISO 1093-1:2018 and testing was carried out to include cytotoxicity to ISO 1099-5:2009 and chemical characterization to ISO 10993-18:2020.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
Magnetic Resonance Imaging safety evaluation testing was performed following ASTM F2.503-13, and the tests evaluated the worstructs for magnetically induced force (ASTM F213-17), image artefact (ASTM F2119-07 (reaproved 2013)) and RF heating (ASTM F2182-19). The testing concluded that there are no safety issues related to magnetic field interactions identified in the labelling.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject C-Stem AMT LE Hip Prosthesis devices are substantially equivalent to the prostheses (KI42959, K08233) and DePay C-Stem System Hip Prostheses (K982918).