510(k) K051510
- Device
- SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
- Applicant
- SIGNAL MEDICAL CORP.
- 510(k) number
- K051510
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-22
- Date received
- 2005-06-07
- Regulation
- 888.3565
- Classification name
- Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOUIS A SERAFIN
- Address
- 400 Pyramid Dr. Marysville MI US 48040 48040
FDA Registration Numbers#
- 3010155661
- 3012491394
- 3030412764
- 3021008900
- 2183946
- 3013176080
- 1423662
- 3002808022
- 3011187779
- 3009760038
- 3009475821
- 3008572101
- 3011461101
- 2242737
- 3005360851
- 3006791286
- 3014302784
- 1526534
- 3017397663
- 1643264
- 3002806470
- 3012725451
- 3002806603
- 3002579136
- 9613369
- 3008868758
- 9613350
- 1226544
- 3005874553
- 3009923578
- 1530390
- 3005581234
- 3009293341
- 3003541440
- 3005718816
- 3010375065
- 3004153240
- 3010041693
- 2245304
- 1645151
- 1835572
- 3003477135
- 3009973505
- 1057425
- 3011724582
- 3012319330
- 3011295718
- 3010009693
- 3010047402
- 3009555440
- 3020703621
- 1721676
- 3010388970
- 1835444
- 1220477
- 3005852519
- 2648920
- 2528981
- 3015542154
- 1221763
- 3007913880
- 3010039400
- 1646498
- 3010386387
- 3015806723
- 3008812251
- 9681642
- 3004450489
- 8010379
- 8043792
- 3002807310
- 1226188
- 1038671
- 3012130008
- 1020279
- 1828288
- 2183744
- 3014162916
- 1219655
- 1822565
Source Documents#
Other 510(k) Records For Product Code MBH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026-09-08 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026-08-21 |
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026-05-28 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026-03-09 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025-07-31 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025-03-27 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases