FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Conformis BeneFIT Hip System
K Number: K190904
·
Decision Aug 28, 2019
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
60
Review Days
142
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Conformis BeneFIT Hip System
- K Number
- K190904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conformis, Inc.
- Date Received
- April 8, 2019
- Decision Date
- August 28, 2019
- Product Code
- LPH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPH), ordered by most recent decision date.
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
FDA 510(k)
FDA Class 2
·Orthopedic
Taperloc® Complete Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
G7® Revision Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Mpact 3D Metal Implants Extension DMLS Technology
FDA 510(k)
FDA Class 2
·Orthopedic
Velora Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
TaperSet Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Conformis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | Sep 8, 2023 | Substantially Equivalent |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | Jul 21, 2023 | Substantially Equivalent |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Jul 17, 2023 | Substantially Equivalent |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | May 26, 2023 | Substantially Equivalent |
| K231178 | ACTERA hip system | May 23, 2023 | Substantially Equivalent |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | Apr 27, 2023 | Substantially Equivalent |
| K221104 | Actera hip system | Aug 4, 2022 | Substantially Equivalent |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Jul 26, 2022 | Substantially Equivalent |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | May 10, 2022 | Substantially Equivalent |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | Nov 10, 2021 | Substantially Equivalent |