(85 days)
Not Found
No
The document describes a mechanical implant (femoral stem) and its physical properties and testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a medical implant (femoral stem for total hip arthroplasty) intended to treat various joint diseases and deformities, which falls under the definition of a therapeutic device.
No
The device is a modular femoral stem intended for use in total hip arthroplasty, which is a treatment or replacement procedure, not a diagnostic one. Its purpose is to attain fixation and restore hip biomechanics, not to identify or characterize a disease or condition.
No
The device description clearly indicates it is a physical implant (femoral stem) made of hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "total hip arthroplasty," which is a surgical procedure involving the replacement of a joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a "modular femoral replacement system" designed to be "press-fit into a prepared femoral canal." This describes a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens 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 biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and,
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.
The subject Restoration Modular 115mm Conical Distal Stem is a sterile, single-use device intended for use in total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, MEH, KWZ, JDI, MAY, MBL
Device Description
The subject Restoration Modular 115mm Conical Distal Stem is a line extension to the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.
The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Performance Data:
The following non-clinical laboratory testing and engineering analyses were conducted to determine substantial equivalence:
- Distal Stem Fatigue Testing per ISO 7206-4:2010/AMD 1:2016
- Biocompatibility evaluated per ISO 10993-1:2018
- Biocompatibility of the device packaging evaluated per ASTM F2475-20
- Shelf-life validated per the following standards:
- ISO 11607-1:2019
- ISO 11607-2:2019
- ASTM F1980-16
- Testing performed per the following methods:
- ASTM F1886/F1886M-16
- ASTM F1929-15
- ASTM F88/88M-15
- ASTM F2096-11(2019)
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2019 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
December 21, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & 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.
Howmedica Osteonics Corp., dba Stryker Orthopaedics Allison Byrne Senior Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K213129
Trade/Device Name: Restoration Modular 115mm Conical Distal 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: LZO, LPH, MEH, KWZ, JDI, MAY, MBL Dated: September 23, 2021 Received: September 27, 2021
Dear Allison Byrne:
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
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)
K213129
Device Name
Restoration Modular 115mm Conical Distal Stem
Indications for Use (Describe)
-
· Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
· Rheumatoid arthritis; -
· Correction of functional deformity;
-
· Revision procedures where other treatments or devices have failed; and,
-
· Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
-
Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Sponsor | Howmedica Osteonics Corp. d/b/a Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allison Byrne
Senior Specialist, Regulatory Affairs
Stryker Orthopaedics
Allison.byrne@stryker.com
Ph: 201-831-5969 |
| Alternate Contact: | Krutanjali Shah
Senior Manager, Regulatory Affairs
Stryker Orthopaedics
Krutanjali.shah@stryker.com
Ph: 201-831-5665 |
| Date Prepared: | September 23rd, 2021 |
| Proprietary Name: | Restoration Modular 115mm Conical Distal Stem |
| Common Name: | Total Hip Joint Replacement |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (21 CFR § 888.3353)
Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (21 CFR § 888.3358)
Hip joint metal/polymer constrained cemented or uncemented
prosthesis (21 CFR § 888.3310)
Hip joint metal/polymer semi-constrained cemented prosthesis (21
CFR § 888.3350) |
| Product Codes: | LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous, uncemented
LPH - prosthesis, hip, semi-constrained, metal/polymer, porous
uncemented
MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer,
non-porous, calcium-phosphate
KWZ - prosthesis, hip, constrained, cemented or uncemented,
metal/polymer
JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented
MAY - prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous cemented, osteophilic finish |
4
MBL - prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:
Reason for 510(k) Submission:
The purpose of this submission is to introduce a line extension to the Restoration® Modular Hip System, specifically a new straight, conical distal stem.
Device Description:
The subject Restoration Modular 115mm Conical Distal Stem is a line extension to the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.
The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.
Intended Use:
The subject Restoration Modular 115mm Conical Distal Stem is a sterile, single-use device intended for use in total hip arthroplasty.
Indications for Use:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular ● necrosis;
- . Rheumatoid arthritis;
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed; and
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
- . Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.
Summary of Technological Characteristics:
The Restoration Modular Conical Distal Stem is a sterile, single-use device that is intended to be press-fit into a prepared proximal femur for cementless fixation in either primary or revision total hip arthroplasty. The predicate device is the straight Restoration Modular Conical Distal Stem, herein referred to as the predicate Restoration Modular Conical Distal Stem. The predicate
5
Restoration Modular Conical Distal Stem is currently available in 2 lengths, 155mm or 195mm, each available in 15 diameters ranging from 14mm to 28mm (in increments of 1mm). The subject device introduces an additional straight conical distal stem component into the currently marketed Restoration Modular Hip System. The subject device is herein referred to as the Restoration Modular 115mm Conical Distal Stem and is available in 12 diameters ranging from 12mm to 23mm (in increments of 1mm).
The predicate Restoration Modular Conical Distal Stem and the subject Restoration Modular 115mm Conical Distal Stem are both straight, conical, fluted components with a taper extending the length of the stem, leading to a diametrically larger proximal section and smaller distal section. Both stems are machined from Ti-6A1-4V ELI alloy per ASTM F136 that is shot peened and then grit blasted after machining. They share an identical male locking taper that mates with the currently marketed compatible cone and calcar proximal femoral bodies.
Non-Clinical Performance Data:
The following non-clinical laboratory testing and engineering analyses were conducted to determine substantial equivalence:
- Distal Stem Fatigue Testing per ISO 7206-4:2010/AMD 1:2016 ●
- Biocompatibility evaluated per ISO 10993-1:2018 ●
- Biocompatibility of the device packaging evaluated per ASTM F2475-20
- Shelf-life validated per the following standards: ●
- ISO 11607-1:2019 O
- o ISO 11607-2:2019
- ASTM F1980-16 O
- Testing performed per the following methods: O
- ASTM F1886/F1886M-16 ■
- ASTM F1929-15
- ASTM F88/88M-15
- l ASTM F2096-11(2019)
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2019 was used for . pyrogenicity testing to achieve an endotoxin limit of