(74 days)
No
The document describes a physical medical device (hip stem) and its materials, design, and performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
Yes
The device is a prosthetic implant (hip stem) used to replace parts of the hip joint, which is a therapeutic intervention for certain painful and disabling joint conditions.
No
This device is described as a hip stem used in arthroplasty procedures, which is a therapeutic device for replacing damaged hip joints, not a device for diagnosing conditions.
No
The device description clearly states it is a physical hip stem manufactured from Ti-6Al-4V ELI alloy with specific coatings and sizes. The performance studies also detail physical and mechanical testing of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip arthroplasty, addressing painful joint disease, revisions, deformities, and fractures. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details a sterile, single-use hip stem made of Ti-6Al-4V ELI alloy with specific coatings and design features for surgical implantation. This aligns with a medical device for surgical intervention.
- 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.
- Performance Studies: The performance studies listed are related to the mechanical properties, fatigue strength, and biocompatibility of the implant, which are typical for surgical devices, not IVDs.
Therefore, the Insignia Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
- · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
· Correction of functional deformity
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks
Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO, LWJ, KWL, KWZ, KWY, JDI, LPH
Device Description
The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty. The basic design of the Insignia Hip Stem is similar to other commercially distributed hip stems, such as the Accolade II and Omnifit HFx hip stems. The Insignia Hip Stem is manufactured from Ti-6Al-4V ELI alloy, features a collar, commercially pure titanium plasma sprayed proximal surface, and plasma sprayed hydroxyapatite coating.
The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics femoral heads, sleeves, and cemented or uncemented acetabular components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Non-Clinical Testing: The following non-clinical laboratory testing was performed, or engineering analysis was conducted to determine substantial equivalence:
- Distal Stem Fatigue Testing per ISO 7206-4
- Neck Fatigue Testing per ISO 7206-6
- Range of Motion Analysis per ISO 21535
- Characterization of the Chemistry, Physical and Mechanical Properties of the coated surfaces:
- Calcium to Phosphorus Ratio
- Crystallinity and Phase Purity
- Preferred Orientation, Crystallite Size and Strain
- Trace Element Analysis
- Solubility Product
- Fourier Transform Infrared (FTIR) Spectroscopy
- Dissolution Rate
- HA Particle Size Distribution
- Titanium Particle Size Distribution
- Shear Fatigue Bond Strength
- Abrasion Resistance
- 4 Point Median Fatigue Strength
- Static Shear Bond Strength
- Tensile Bond Strength
- Volume % Voids
- Void Intercept Length
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an endotoxin limit of
§ 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
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.
August 16, 2021
Stryker Orthopaedics % Gregg Ritter Senior Staff Specialist. Regulatory Affairs Howmedica Osteonics Corp aka Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430
Re: K211703
Trade/Device Name: Insignia Hip Stem 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, LZO, LWJ, KWL, KWZ, KWY, JDI, LPH Dated: June 2, 2021 Received: June 3, 2021
Dear Gregg Ritter:
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.
Limin Sun, Ph.D. Acting 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)
Device Name Insignia Hip Stem
Indications for Use (Describe) Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
- · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
· Correction of functional deformity
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks
Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ü 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
| Sponsor: | Howmedica Osteonics Corp. d/b/a Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared By: | Valerie Giambanco, Regulatory Affairs Manager, Stryker |
| Contact Person: | Gregg Ritter
Senior Staff Specialist, Regulatory Affairs
Stryker Orthopedics
Gregg.ritter@stryker.com
Ph: 201-831-5665 |
| Alternate Contact: | Krutanjali Shah
Senior Manager, Regulatory Affairs
Stryker Orthopaedics
Krutanjali.shah@stryker.com
Ph: 845-213-8762 |
| Date Prepared: | June 3, 2021 |
| Proprietary Name: | Insignia Hip Stem |
| Common Name: | Hip Joint Prosthesis |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (888.3353)
Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis (888.3360)
Hip joint metal/polymer constrained cemented or uncemented
prosthesis (888.3310)
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or
Uncemented (888.3390)
Hip joint metal/polymer semi-constrained cemented prosthesis
(888.3350)
Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (888.3358) |
| Product Codes: | MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer,
non-porous, calcium-phosphate
LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous, uncemented
LWJ - prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWL - prosthesis, hip, hemi-, femoral, metal |
4
KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer
KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Legally Marketed Primary Predicate Devices to Which Substantial Equivalence is Claimed:
Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence:
Device Description:
The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty. The basic design of the Insignia Hip Stem is similar to other commercially distributed hip stems, such as the Accolade II and Omnifit HFx hip stems. The Insignia Hip Stem is manufactured from Ti-6Al-4V ELI alloy, features a collar, commercially pure titanium plasma sprayed proximal surface, and plasma sprayed hydroxyapatite coating.
The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics femoral heads, sleeves, and cemented or uncemented acetabular components.
Intended Use:
The Insignia Hip Stem is intended for use in primary and revision total and hemi hip arthroplasty to alleviate pain and restore function.
Indications for Use:
The Insignia Hip stem has similar Indications for Use as the Accolade II Hip Stem.
Hip Arthroplasty Indications
-
- Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or posttraumatic arthritis.
-
- Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
-
- Correction of functional deformity
- 4.Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
5
Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, . the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
- When the stem is to be used with compatible Howmedica Osteonics ADM and MDM . Acetabular Components, the device is indicated for Dislocation risks.
Insignia Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
Summary of Technological Characteristics: Device comparisons and performance testing show that the Insignia Hip Stem is substantially equivalent to the primary predicate Accolade II Hip Stem device in terms of intended use, indications for use, size-specific medial curvature design, materials, performance characteristics and operational principles. The primary predicate Accolade II Hip Stem does not have a collar or HA coating on the distal stem region. The Insignia Hip Stem device is similar in design to the additional predicate Omnifit HFx Hip Stem as both are collared stems. The Insignia Hip Stem is similar to the additional predicate Actis Hip Stem as both have a collar with a hydroxyapatite (HA) coated underside and are both fully HA coated in the distal and proximal stem regions.
Non-Clinical Testing: The following non-clinical laboratory testing was performed, or engineering analysis was conducted to determine substantial equivalence:
- Distal Stem Fatigue Testing per ISO 7206-4 ●
- Neck Fatigue Testing per ISO 7206-6
- Range of Motion Analysis per ISO 21535 ●
- Characterization of the Chemistry, Physical and Mechanical Properties of the coated surfaces:
| Test | Method |
|---|---|
| Calcium to Phosphorus Ratio | ISO 13779-3:2018 |
| Crystallinity and Phase Purity | ISO 13779-3:2018 |
| Preferred Orientation, Crystallite Size and Strain | X-Ray Diffraction |
| Trace Element Analysis | ISO 13779-3:2018 |
| Solubility Product | ISO 13779-6:2015 |
| Fourier Transform Infrared (FTIR) Spectroscopy | ISO 13779-2:2018 & ISO 13779-6:2015 |
| Dissolution Rate | ASTM F-1926M-14 |
| HA Particle Size Distribution | ISO 13779-6:2015 |
6
| Titanium Particle Size Distribution | ASTM B214 or ASTM B822 |
|---|---|
| Shear Fatigue Bond Strength | ASTM F-1044-05 & ASTM F-1160-14 |
| Abrasion Resistance | Stryker Internal Method |
| 4 Point Median Fatigue Strength | ASTM F-1160-14 |
| Static Shear Bond Strength | ASTM F-1044-05 |
| Tensile Bond Strength | ASTM F-1147-05 |
| Volume % Voids | ASTM F-1854-15 |
| Void Intercept Length | ASTM F-1854-15 |
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for ● pyrogenicity testing to achieve an endotoxin limit of