(43 days)
The Implex Cobrex Hip Stem is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented or hybrid total hip arthroplasty.
The Implex Cobrex Hip Stem, cemented, is a modular femoral hip stem manufactured from forged cobalt chromium alloy conforming to ASTM F-799. The Cobrex hip stem has a 12/14 taper and is available in five stem sizes (10, 11, 12, 13, and 14) with proportionally increasing neck offsets (24 mm, 30 mm, and 36 mm). Also, the Cobrex hip stem is collared with a cobra type flange on the proximal section.
The provided text is a 510(k) summary for the Implex Cobrex Hip System, Femoral Component. It describes the device, its indications for use, and a conclusion of substantial equivalence to predicate devices based on technological characteristics and performance data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., maximum stress, minimum cycles to failure) or reported numerical performance data. Instead, it refers to a type of test and a conclusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Fatigue Performance | "Fatigue testing has been provided to demonstrate that the Cobrex hip stem will perform as intended." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the fatigue testing, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is physical fatigue testing of a mechanical device, not a study requiring expert interpretation of clinical data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the study described is physical fatigue testing of a mechanical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a hip implant, not an AI-based diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a hip implant, not an algorithm. The "standalone" performance here refers to the device's mechanical integrity under fatigue loading.
7. The type of ground truth used
The "ground truth" for this type of device is its ability to withstand mechanical stresses and cyclic loading over its intended lifespan without failure. This is established through mechanical fatigue testing which simulates in-vivo conditions to demonstrate expected performance and durability. Specific failure points or acceptable deformation levels would be predefined based on engineering standards (like ASTM F-799 mentioned in the device description).
8. The sample size for the training set
This is not applicable as the device is a mechanical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a mechanical implant, not an AI model.
Summary of what is known from the document:
- Acceptance Criteria/Performance: The device underwent "fatigue testing" to demonstrate it "will perform as intended." The specific criteria for "perform as intended" are not detailed but are implied to be sufficient for substantial equivalence.
- Study Type: Mechanical fatigue testing.
- Device Type: Femoral component of a hip prosthesis.
- Material: Forged cobalt chromium alloy conforming to ASTM F-799.
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Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '991869'. The characters are handwritten and slightly slanted to the right.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | John Schalago or Robert Poggie |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | May 28, 1999 |
| Device Trade Name: | Implex Cobrex Hip System, Femoral Component |
| Device Common Name: | Hip Prosthesis, Femoral Component Cemented orUncemented |
| Classification Numberand Name: | 21 CFR § 888.3360 |
| Substantial Equivalence: | The term "substantial equivalence" as used in this510(k) notification is limited to the definition ofsubstantial equivalence found in the Federal Food,Drug and Cosmetic Act, as amended and as appliedunder 21 CFR 807, Subpart E under which a devicecan be marketed without premarket approval orreclassification. A determination of substantialequivalency under this notification is not intended tohave any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters.No statements related to, or in support of substantialequivalence herein shall be construed as anadmission against interest under the US Patent Lawsor their application by the courts. |
| Device Description: | The Implex Cobrex Hip Stem, cemented, is a modularfemoral hip stem manufactured from forged cobaltchromium alloy conforming to ASTM F-799. The Cobrexhip stem has a 12/14 taper and is available in five stemsizes (10, 11, 12, 13, and 14) with proportionallyincreasing neck offsets (24 mm, 30 mm, and 36 mm).Also, the Cobrex hip stem is collared with a cobra typeflange on the proximal section. |
| Indications for Use: | The Implex Cobrex Hip Stem is intended for use wheresevere degeneration, trauma, or other pathology of the hipjoint indicates cemented or hybrid total hip arthroplasty. |
| Device TechnologicalCharacteristics andComparison toPredicate Device: | A comparison of technological characteristics of thesubject and predicate devices supports a determination ofsubstantial equivalence. |
| Performance Data: | Fatigue testing has been provided to demonstrate that theCobrex hip stem will perform as intended. |
| Conclusion: | The Implex Cobrex Hip Stem is substantially equivalent tothe identified predicate devices. |
The Cobrex Hip Stem is intended for cemented use with Continuum® Hip Stem Components only.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the caduceus in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Mr. John A Schalago Regulatory Affairs Manager Implex® Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K991869 Trade Name: Cobrex Hip Stem Regulatory Class: II Product Code: JDI Dated: May 28, 1999 Received: June 1, 1999
Dear Mr. Schalago:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John A. Schalago
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Collin Wilcox, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Cobrex Hip Stem |
|---|
| Implex Corp |
| 510(k) Number (if known): | K991869 |
|---|---|
| --------------------------- | --------- |
Device Name:
Cobrex Hip Stem
Indications For Use:
The Implex Cobrex Hip Stem is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented or hybrid total hip arthroplasty.
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Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR...
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991869
§ 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.