(60 days)
Not Found
No
The device description focuses on the material composition and mechanical design of a hip implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are non-clinical and relate to material properties and fatigue testing.
Yes
The device, a hip stem prosthesis, is used to replace a damaged hip joint and restore its function, directly addressing a medical condition (pain, disability, necrosis, fracture) to improve a patient's health and quality of life.
No
The device is described as a hip replacement prosthesis (femoral stem) and its intended use is to replace a diseased or damaged hip joint, which is a therapeutic function, not diagnostic.
No
The device description clearly details a physical hip stem implant made of titanium with porous coating and hydroxyapatite coating, which is a hardware medical device.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Summit DuoFix Hip is a "non-modular, collarless, Titanium, tapered, press-fit femoral stem." This is a physical implant designed to replace a part of the hip joint.
- Intended Use: The intended use describes conditions requiring total or hemi hip replacement, which are surgical procedures involving the implantation of this device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Summit DuoFix Hip is an orthopedic implant, not an in vitro diagnostic device.
N/A
# Intended Use / Indications for Use
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.
Hemi hip replacement is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty
# Product codes
MEH, LPH
# Device Description
The Summit DuoFix Hip is identical to the previously cleared Titanium Porocoat Hip stem ([K170339](https://510k.innolitics.com/search/K170339), [K011489](https://510k.innolitics.com/search/K011489), [K001911](https://510k.innolitics.com/search/K001911)) except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface. The Summit DuoFix Hip is a non-modular, collarless, Titanium, tapered, press-fit femoral stem. The hip stem is manufactured from ASTM F-620-87 forged Titanium (Ti-6Al-4V) and has a sintered commercially pure Titanium bead porous coating (Porocoat®) applied to the stem. The porous coating is applied over the circumferential ridges on the proximal region of the stem. A thin coating of hydroxyapatite (HA) is sprayed over the porous coating in a uniform thickness via a plasma spray process. The HA powder used in the plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process to apply the HA coating to the Summit DuoFix Stem is the same process used to coat the Pinnacle Duofix Acetabular Cup which was cleared in [K192919](https://510k.innolitics.com/search/K192919). The HA material used for the Summit DuoFix Stem is the same as the HA material used on the Pinnacle Duofix Acetabular Cup. The distal portion of the stem has a grit blast surface finish. The hip stem consists of 10 body sizes ranging in diameter from 7 mm to 18 mm with each body size having two offset options. The design is a medially rounded trapezoid with a longitudinal ridge to optimize distal rotational stability. The Summit DuoFix hip stem uses a 12/14 taper for attachment of femoral ball heads. Femoral ball heads are intended to be used with the Summit DuoFix Hip prosthesis to provide the femoral prosthetic articular surface for the total hip arthroplasty. The femoral head articulates with an acetabular cup prosthesis that functions to restore mobility of the hip.
# 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
younger patients, elderly
# 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)
The following tests were performed on the Summit Hip to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- Sterilization validation per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ISO 11137-2: 2013
- Characterization testing of Hydroxyapatite Coating as recommended per FDA Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
- Stem Fatigue Testing as per ISO 7206-4: 2010 Implants for surgery Partial and total hip protheses- Part 4 Determination of endurance properties and performance of stemmed femoral components
No clinical tests were necessary to clear the current device and thus no clinical testing was conducted here to demonstrate substantial equivalence.
The subject DePuy Summit Hip products are substantially equivalent to the predicate Summit Hip products ([K170339](https://510k.innolitics.com/search/K170339), [K011489](https://510k.innolitics.com/search/K011489) and [K001991](https://510k.innolitics.com/search/K001991))
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s)
[K170339](https://510k.innolitics.com/search/K170339), [K011489](https://510k.innolitics.com/search/K011489), [K001911](https://510k.innolitics.com/search/K001911)
# 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
February 4, 2020
Image /page/0/Picture/1 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. Margaret Shaughnessy Regulatory Affairs Project Leader DePuy (Ireland) Loughbeg, Ringaskiddy Cork, Co.Cork Munster P43ED82 IE
Re: K193398
Trade/Device Name: Summit DuoFix™ HA Coating 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: MEH, LPH Dated: January 7, 2020 Received: January 8, 2020
Dear Margaret Shaughnessy:
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.
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
1
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 (OS) 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 mediation-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 Vesa Vuniqi, MS 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
2
Indications for Use
510(k) Number (if known) K193398
Device Name Summit DuoFix™ HA Coating
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 treation.
-
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
| 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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3
510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics |
| Address | 700 Orthopedic Drive |
| Warsaw, IN 46582 | |
| Phone number | 574 372 7020 |
| Fax number | 574- 371-4987 |
| Establishment Registration | |
| Number | 1818910 |
| Name of contact person | Margaret Shaughnessy |
| Date prepared | 28th January 2020 |
| Name of device | |
| Trade or proprietary name | Summit DuoFix™ HA Coating |
| 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 | 888.3358 |
| Product Code(s) | MEH, LPH |
| Legally marketed device(s) to | |
| which equivalence is claimed | DePuy Porocoat Hip Prosthesis – K170339, K011489, K001911 |
| Reason for 510(k) submission | The purpose of this submission is to support the manufacturing of the subject |
| Summit DuoFix™ HA Coating components at an additional manufacturing | |
| facility for all process steps currently performed at DePuy Ireland. This | |
| includes the HA coating process step within the DePuy Ireland manufacturing | |
| site. There is also the addition of two alternative sterilization sites being added | |
| for Business Continuity Purposes. Finally, there is a modification to the | |
| packaging; converting from an outer thermoformed blister package and film | |
| pouch inner to a polyurethane sleeve protector which is vacuumed sealed in a | |
| nylon pouch which is placed inside an outer PETG blister sealed with a Tyvek | |
| lid. There are no other modifications to the product associated with these | |
| changes in comparison with the currently marketed Summit Hip System – the | |
| predicate and proposed device share the same intended use, product design, principle of operation, and materials. | |
| Device description | The Summit DuoFix Hip is identical to the previously cleared Titanium |
| Porocoat Hip stem (K170339, K011489, K001911) except for the presence of | |
| a thin layer of hydroxyapatite coating applied to the porous coated surface. | |
| The Summit DuoFix Hip is a non-modular, collarless, Titanium, tapered, | |
| press-fit femoral stem. The hip stem is manufactured from ASTM F-620-87 | |
| forged Titanium (Ti-6Al-4V) and has a sintered commercially pure Titanium | |
| bead porous coating (Porocoat®) applied to the stem. The porous coating is | |
| applied over the circumferential ridges on the proximal region of the stem. | |
| A thin coating of hydroxyapatite (HA) is sprayed over the porous coating in | |
| a uniform thickness via a plasma spray process. The HA powder used in the | |
| plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 | |
| Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process to apply | |
| the HA coating to the Summit DuoFix Stem is the same process used to coat | |
| the Pinnacle Duofix Acetabular Cup which was cleared in K192919. The HA | |
| material used for the Summit DuoFix Stem is the same as the HA material | |
| used on the Pinnacle Duofix Acetabular Cup. | |
| The distal portion of the stem has a grit blast surface finish. The hip stem | |
| consists of 10 body sizes ranging in diameter from 7 mm to 18 mm with each | |
| body size having two offset options. The design is a medially rounded | |
| trapezoid with a longitudinal ridge to optimize distal rotational stability. | |
| The Summit DuoFix hip stem uses a 12/14 taper for attachment of femoral ball | |
| heads. Femoral ball heads are intended to be used with the Summit DuoFix | |
| Hip prosthesis to provide the femoral prosthetic articular surface for the total | |
| hip arthroplasty. The femoral head articulates with an acetabular cup | |
| prosthesis that functions to restore mobility of the hip. | |
| 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 | |
| Indications for use | 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. |
| Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Hemi hip replacement is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. | |
| 6. Degenerative arthritis involving only the femoral head in which | |
| the acetabulum does not require replacement. | |
| 7. Pathology involving only the femoral head/neck and/or proximal | |
| femur that can be adequately treated by hemi-hip arthroplasty. |
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K193398 Page 5 of 7
8
| Characteristics | Subject Device:
Summit Hip System | Predicate Device:
Summit Duofix™ HA Hip
Stem Prosthesis - K170339 | Predicate Device:
Summit Hip HA Stem
- K011489 | Predicate Device:
Summit Hip HA Stem - K001991 |
|-----------------|--------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------|
| Shelf Life | 10 Year | Same | Same | Same |
9
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the Summit Hip to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- . Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- Sterilization validation per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ISO 11137-2: 2013
- Characterization testing of Hydroxyapatite Coating as recommended per FDA Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
- Stem Fatigue Testing as per ISO 7206-4: 2010 Implants for surgery Partial and total hip ● protheses- Part 4 Determination of endurance properties and performance of stemmed femoral components
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were necessary to clear the current device and thus no clinical testing was conducted here to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy Summit Hip products are substantially equivalent to the predicate Summit Hip products (K170339, K011489 and K001991)