(147 days)
Not Found
No
The document describes a hip stem implant and its coating, focusing on materials and mechanical performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip stem intended to relieve hip pain and restore hip motion in patients with various conditions such as degenerative joint disease, trauma, and fractures, which are therapeutic goals.
No
The device is a femoral stem used in hip replacement surgery to treat conditions like arthritis and fractures. Its purpose is therapeutic (relieving pain and restoring motion), not diagnostic.
No
The device description explicitly states the device is a "Femoral Stem" made from "forged titanium alloy" with a "double coating". This describes a physical implantable device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the SL-PLUS® MIA Stem and SL-PLUS® Stem are femoral stems intended for surgical implantation in the hip joint to relieve pain and restore motion. They are used in primary and revision hip replacement surgeries.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is mechanical support and replacement within the body.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SL-PLUS® MIA Stem and the SL-PLUS® MIA Stem with Ti/HA (INTEGRATION-PLUS®) is indicated for:
Indications Standard Stem
The SL-PLUS MIA Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications Lateral Stem
The SL-PLUS MIA Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS® Stem and the SL-PLUS® Stem with Ti/HA (INTEGRATION-PLUS®) is indicated for:
Indications Standard Stem
The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head
Indications Lateral Stem
The SL-PLUS Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Product codes
LZO, KWY, LWJ
Device Description
The SL-PLUS® MIA Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ MIA Femoral Stem cleared via K122296. The subject stems are made from forged titanium alloy, Ti-6AI-7Nb, with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite. The Ti/HA coating form Medicoat AG is substantially equivalent to the Ti/HA coating on the SL-PLUS® MIA Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K122296.
The SL-PLUS® Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ Femoral Stem cleared via K120211. The subject stems are made from forged titanium alloy, Ti-6Al-7Nb, with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite. The Ti/HA coating form Medicoat AG is substantially equivalent to the Ti/HA coating on the SL-PLUS™ Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K120211.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
A review of the mechanical data indicates that the SL-PLUS™ MIA and SL-PLUS Femoral Stem with Ti/HA is capable of withstanding expected in vivoloading without failure. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate devices listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping to create a sense of depth and connection. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2015
Smith & Nephew, Incorporated Mr. Jeff Sprague Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K143096
Trade/Device Name: SL-PLUS™ MIA Femoral Stem with Ti/HA and SL-PLUS™ Femoral Stem with Ti/HA 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, KWY, LWJ Dated: February 19, 2015 Received: February 20, 2015
Dear Mr. Sprague:
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE Smith & Nephew SL-PLUS MIA and SL-PLUS Femoral Stem with Ti/HA
510(k) Number (if known): K143096
Device Name: SL-PLUS® MIA Femoral Stem with Ti/HA
Indications for Use:
The SL-PLUS® MIA Stem and the SL-PLUS® MIA Stem with Ti/HA (INTEGRATION-PLUS®) is indicated for:
Indications Standard Stem
The SL-PLUS MIA Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications Lateral Stem
The SL-PLUS MIA Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
INDICATIONS FOR USE Smith & Nephew SL-PLUS° MIA and SL-PLUS Femoral Stem with Ti/HA
510(k) Number (if known): K143096
Device Name: SL-PLUS® Femoral Stem with Ti/HA
Indications for Use:
The SL-PLUS® Stem and the SL-PLUS® Stem with Ti/HA (INTEGRATION-PLUS®) is indicated for:
Indications Standard Stem
The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head
Indications Lateral Stem
The SL-PLUS Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
510(k) Summary Smith & Nephew SL-PLUS™ MIA and SL-PLUS Femoral Stem with Ti/HA
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 27, 2014 |
| Contact Person | Jeff Sprague, Regulatory Affairs
T (901) 399-5215 F (901) 721-2736 |
| Name of Device: | SL-PLUS™ MIA and SL-PLUS Standard and
Lateral Femoral Stem with Ti/HA |
| Common Name: | Total Hip Joint, Femoral Component,
Cementless |
| Device Classification Name and Reference: | 21 CFR 888.3353 –Hip joint
metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented
prosthesis
21 CFR 888.3390 – Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented
prosthesis
21 CFR 888.3360 - Hip joint femoral (hemi-hip
metallic cemented or uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LZO, KWY, LWJ |
Device Description
The SL-PLUS® MIA Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ MIA Femoral Stem cleared via K122296. The subject stems are made from forged titanium alloy, Ti-6AI-7Nb, with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite. The Ti/HA coating form Medicoat AG is substantially equivalent to the Ti/HA coating on the SL-PLUS® MIA Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K122296.
The SL-PLUS® Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ Femoral Stem cleared via K120211. The subject stems are made from forged titanium alloy, Ti-6Al-7Nb, with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite. The Ti/HA coating form Medicoat
5
AG is substantially equivalent to the Ti/HA coating on the SL-PLUS™ Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K120211.
Intended Use
SL-PLUS MIA
The SL-PLUS™ MIA Stem and the SL-PLUS™ MIA Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for:
Indications Standard Stem
The SL-PLUS MIA Hip Stem is indicated for individuals undergoinq primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications Lateral Stem
The SL-PLUS MIA Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
SL-PLUS
The SL-PLUS™ Stem and the SL-PLUS™ Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for:
Indications Standard Stem
The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head
Indications Lateral Stem
The SL-PLUS Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended
6
drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The above indications are substantially equivalent to the indications cleared previously for the SL-PLUS MIA Standard and Lateral Femoral Stem with Ti/HA (K122296) and the SL-PLUS Standard and Lateral Femoral Stem with Ti/HA (K120211).
Technological Characteristics
A review of the mechanical data indicates that the SL-PLUS™ MIA and SL-PLUS Femoral Stem with Ti/HA is capable of withstanding expected in vivoloading without failure.
Substantial Equivalence Information
The overall design, materials, and indications for use for the SL-PLUS™ MIA and SL-PLUS Femoral Stem with Ti/HA are substantially equivalent to the following commercially available predicate devices.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-----------------------------------|---------------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew
Orthopaedics AG | SL-PLUS™ MIA Standard and Lateral Femoral
Stems with Ti/HA | K122296 | 9/28/2012 |
| Smith & Nephew
Orthopaedics AG | SL-PLUS™ Standard and Lateral Femoral Stems
with Ti/HA | K120211 | 7/19/2012 |
The following tests were used as a basis for the determination of substantial equivalence:
- HA powder and coating characterization X
All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF - 2541 and are not included in this 510(k).
Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the SL-PLUS™ MIA Femoral Stem with Ti/HA and SL-PLUS™ Femoral Stem with Ti/HA coated by Medicoat AG. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate devices listed above.