(448 days)
No
The summary describes a series of physical hip stems and their materials, indications, and testing. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is a hip stem used in total or hemi-hip arthroplasty procedures to replace a severely painful and/or disabled joint. This directly addresses and alleviates a medical condition, qualifying it as a therapeutic device.
No
Explanation: The document describes a hip replacement system, which is a prosthetic device implanted in a patient. Its intended use is to replace a damaged hip joint, not to diagnose a condition. The "Indications for Use" section lists conditions that warrant the use of the device, but the device itself does not perform the diagnosis.
No
The device description clearly details physical components made of titanium alloy and cobalt-chromium, which are hardware. The intended use and performance studies also focus on the physical properties and performance of these implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The device described is a series of femoral hip stems, which are implants used in surgical procedures (total or hemi-hip arthroplasty).
- Intended Use: The intended use is for replacing a damaged hip joint due to various conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The text clearly describes a surgical implant used in vivo (within the body) for treatment, not a diagnostic tool used in vitro (outside the body) to analyze samples.
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.
Hemi hip replacement is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, LWJ, LPH, MEH, KWY, LZY, KWL
Device Description
The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices. The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.
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)
To support a determination of substantial equivalence, non-clinical testing/evaluations were conducted.
The following studies were provided:
- Hip Head Center Analysis – Demonstrated that Summit stem hemi-arthroplasty constructs do not introduce new fatigue strength risks when compared to Summit stem total hip arthroplasty constructs.
- Corrosion Analyses - Demonstrated that Summit stem hemi-arthroplasty constructs pose no greater risk for corrosion when compared to the predicate device Summit and/or Actis stems.
- Range of Motion (ROM) Analysis – Concluded that the Summit stem hemi-arthroplasty constructs have ROM equivalent to that of the predicate device Actis stem hemi-arthroplasty constructs.
- Pyrogenicity Testing – Concluded that the subject devices meet the required endotoxin limits
No Clinical tests were required to support this premarket 510(k) submission.
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.
K001991 Titan Porocoat Hip Prosthesis
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.
K011489 Summit Duofix Hip Prosthesis, K013352 Summit Cemented Hip Prosthesis, K023453 DePuy Cemented FX Cemented Hip Prosthesis, K030122 DePuy Summit Basic Press Fit Hip Prosthesis, K150862 DePuy Actis DuoFix Hip Prosthesis, K123991 DePuy Corail AMT Hip Prosthesis
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
§ 888.3353 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.
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Image /page/0/Picture/0 description: The image contains 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.
Depuy Orthopaedics, Inc. Daniel J. Williman Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582
April 26, 2018
Re: K170339
Trade/Device Name: Summit 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, JDI, LWJ, LPH, MEH, KWY, KWL, LZY Dated: March 28, 2018 Received: March 29, 2018
Dear Daniel J. Williman:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170339
Device Name Summit Hip System
Indications for Use (Describe)
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.
Hemi hip replacement is indicated in the following conditions:
-
Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
-
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
-
Avascular necrosis of the femoral head.
-
Non-union of femoral neck fractures.
-
Certain high subcapital and femoral neck fractures in the elderly.
-
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
-
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.
| 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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| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics |
| Address | 700 Orthopedic Drive |
| Warsaw, IN 46582 | |
| Phone number | 574-372-7745 |
| Fax number | 574-371-4987 |
| Establishment Registration | |
| Number | 1818910 |
| Name of contact person | Daniel J. Williman |
| Date prepared | March 28, 2017 |
| Name of device | |
| Trade or proprietary name | Summit Hip System |
| Common or usual name | Hip Joint Replacement Prosthesis |
| Classification name | Hip joint metal/ceramic/polymer semi-constrained cemented or non- |
| porous uncemented prosthesis; | |
| Class | II |
| Classification panel | 87 Orthopedic and Rehabilitation Devices |
| Regulation | 21 CFR 888.3353, 888.3350, 888.3358, 888.3360, and 888.3390 |
| Product Codes | LZO, JDI, LWJ, LPH, MEH, KWY, LZY, KWL |
| Predicate Devices | K001991 Titan Porocoat Hip Prosthesis |
| K011489 Summit Duofix Hip Prosthesis | |
| K013352 Summit Cemented Hip Prosthesis | |
| K023453 DePuy Cemented FX Cemented Hip Prosthesis | |
| K030122 DePuy Summit Basic Press Fit Hip Prosthesis | |
| K150862 DePuy Actis DuoFix Hip Prosthesis | |
| K123991 DePuy Corail AMT Hip Prosthesis | |
| Reason for 510(k) Submission | The purpose of this submission is to append to the existing |
| indication for use statement to include hemi-hip replacement for the | |
| Summit Hip System. | |
| Device description | The Summit Hip System is series of tapered femoral hip stems |
| which may be used in either total or hemi-hip arthroplasty | |
| procedures in conjunction with DePuy hip arthroplasty devices. | |
| The Summit Porous Hip Prosthesis is a series of collarless, titanium, | |
| tapered, press fit femoral stems The hip stem is manufactured from | |
| titanium alloy (Ti-6Al-4V) and has a sintered commercially pure | |
| titanium bead porous coating (Porocoat) applied to the stem. There | |
| are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm | |
| (Size 10) with each body size having two offset options. These | |
| stems are intended for uncemented use only. | |
| The Summit DuoFix Porous Hip Prosthesis is a series of collarless, | |
| titanium alloy, tapered, press-fit femoral stems. The hip stem is | |
| manufactured from titanium alloy (Ti-6Al-4V) and has a sintered | |
| commercially pure titanium bead porous coating (Porocoat) applied | |
| to the stem with a thin layer of hydroxyapatite (HA) coating. There | |
| are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm | |
| (Size 10) with each body size having two offset options. These | |
| stems are intended for uncemented use only. | |
| The Summit Cemented Hip Prosthesis is series a flanged, collared | |
| tapered Cobalt-Chromium femoral stems with a smooth finish. | |
| There are seven proportional body sizes with a standard offset, and | |
| six proportional body sizes with a high offset. Distal and proximal | |
| PMMA centralizers help assure the stem is centered in the femoral | |
| canal. These stems are intended for cemented use only. | |
| The Summit Basic Cemented Hip Prosthesis is a series of flanged, | |
| collared, tapered Cobalt-Chromium-Molybdenum femoral stems | |
| with a smooth surface finish. There are seven total sizes with a | |
| constant offset. Only six of the seven sizes are available in the high | |
| offset option. A distal PMMA centralizer helps assure that the stem | |
| is centered in the femoral canal. These stems are intended for | |
| cemented use only. | |
| The Summit Basic Press Fit Hip Prosthesis is a series of collared, | |
| tapered Titanium femoral stem with a grit-blasted finish. There are | |
| seven sizes with a constant offset and a distal centralizer to assure | |
| that the stem is centered in the femoral canal. These stems are | |
| intended for uncemented use only. | |
| Intended use of the device | Total and hemi-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. | |
| Total or hemi-hip arthroplasty may be considered for younger | |
| patients if, in the opinion of the surgeon, an unequivocal indication | |
| for total or hemi-hip replacement outweighs the risks associated | |
| with the age of the patient and if limited demands regarding activity | |
| and hip joint loading can be assured. This includes severely crippled | |
| patients with multiple joint involvement for whom a gain in hip | |
| mobility may lead to an expectation of significant improvement in | |
| the quality of their lives. | |
| 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
dislocation. |
| 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.
Hemi hip replacement is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be
appropriately reduced and treated with internal fixation. - Fracture dislocation of the hip that cannot be appropriately reduced
and treated with internal fixation. - Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which
the acetabulum does not require replacement. - Pathology involving only the femoral head/neck and/or proximal
femur that can be adequately treated by hemi-hip arthroplasty.
The SUMMIT POROCOAT Porous, SUMMIT DuoFix
Porous, and SUMMIT Basic Press Fit stems are indicated for
uncemented use only. The SUMMIT Cemented and SUMMIT
Basic Cemented stems are indicated for cemented use only. | |
| SUBSTANTIAL EQUIVALENCE INFORMATION | |
| The subject and predicate Summit stem devices are identical in design, materials, and coatings. Non-
clinical testing demonstrated performance equivalence between the subject and predicate devices. | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE | |
| To support a determination of substantial equivalence, non-clinical testing/evaluations were conducted. | |
| The following studies were provided:
● Hip Head Center Analysis – Demonstrated that Summit stem hemi-arthroplasty constructs do not
introduce new fatigue strength risks when compared to Summit stem total hip arthroplasty
constructs.
● Corrosion Analyses - Demonstrated that Summit stem hemi-arthroplasty constructs pose no
greater risk for corrosion when compared to the predicate device Summit and/or Actis stems.
● Range of Motion (ROM) Analysis – Concluded that the Summit stem hemi-arthroplasty
constructs have ROM equivalent to that of the predicate device Actis stem hemi-arthroplasty
constructs.
● Pyrogenicity Testing – Concluded that the subject devices meet the required endotoxin limits | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| No Clinical tests were required to support this premarket 510(k) submission. | |
510(k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93)
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