Advance®
Advance® II Modular Titanium Tibial Base SZ 3 STD Nonporous
10manufacturers in China registered for this device type
67catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-20 |
| Record revised | 2019-12-11 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 10 to 25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIPS2310 | Height 10 mm | In distribution |
| KIPS2417 | Height 17 mm | In distribution |
| KTTINP30 | In distribution | |
| KIPS2317 | Height 17 mm | In distribution |
| KTCCNP60 | In distribution | |
| KIPS1510 | Height 10 mm | In distribution |
| KIPS1412 | Height 12 mm | In distribution |
| KTCCNP10 | In distribution | |
| KIPS2612 | Height 12 mm | In distribution |
| KIPS0417 | Height 17 mm | In distribution |
| KIPS2220 | Height 20 mm | In distribution |
| KIPS2112 | Height 12 mm | In distribution |
| KIPS2414 | Height 14 mm | In distribution |
| KIPS0414 | Height 14 mm | In distribution |
| KIPS2312 | Height 12 mm | In distribution |
| KIPS2610 | Height 10 mm | In distribution |
| KIPS2117 | Height 17 mm | In distribution |
| KTTINP25 | In distribution | |
| KTTINP20 | In distribution | |
| KTCCNP20 | In distribution | |
| KIPS2614 | Height 14 mm | In distribution |
| KIPS2214 | Height 14 mm | In distribution |
| KIPS0317 | Height 17 mm | In distribution |
| KIPS2320 | Height 20 mm | In distribution |
| KIPS0625 | Height 25 mm | In distribution |
| KTCCNP11 | In distribution | |
| KIPS1310 | Height 10 mm | In distribution |
| KIPS2212 | Height 12 mm | In distribution |
| KIPS0314 | Height 14 mm | In distribution |
| KTCCNP50 | In distribution | |
| KTCCNP41 | In distribution | |
| KIPS2412 | Height 12 mm | In distribution |
| KTCCNP25 | In distribution | |
| KIPS2525 | Height 25 mm | In distribution |
| KIPS2617 | Height 17 mm | In distribution |
| KIPS2517 | Height 17 mm | In distribution |
| KIPS2625 | Height 25 mm | In distribution |
| KIPS1612 | Height 12 mm | In distribution |
| KIPS2420 | Height 20 mm | In distribution |
| KIPS2410 | Height 10 mm | In distribution |
| KIPS0214 | Height 14 mm | In distribution |
| KTTINP40 | In distribution | |
| KIPS2514 | Height 14 mm | In distribution |
| KTCCNP31 | In distribution | |
| KIPS2510 | Height 10 mm | In distribution |
| KIPS2120 | Height 20 mm | In distribution |
| KIPS2512 | Height 12 mm | In distribution |
| KTCCNP51 | In distribution | |
| KTCCNP21 | In distribution | |
| KIPS1312 | Height 12 mm | In distribution |
| KIPS1212 | Height 12 mm | In distribution |
| KIPS2520 | Height 20 mm | In distribution |
| KIPS2425 | Height 25 mm | In distribution |
| KIPS2125 | Height 25 mm | In distribution |
| KIPS1210 | Height 10 mm | In distribution |
| KIPS2217 | Height 17 mm | In distribution |
| KTCCNP40 | In distribution | |
| KIPS2210 | Height 10 mm | In distribution |
| KIPS2314 | Height 14 mm | In distribution |
| KIPS2620 | Height 20 mm | In distribution |
| KTCCNP30 | In distribution | |
| KIPS2225 | Height 25 mm | In distribution |
| KIPS2325 | Height 25 mm | In distribution |
| KIPS2110 | Height 10 mm | In distribution |
| KIPS1410 | Height 10 mm | In distribution |
| KIPS2114 | Height 14 mm | In distribution |
| KIPS0217 | Height 17 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152631 | 2016-03-23 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-05-03 | Class II | Under Investigation by firm | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Fe | 40 units | |
| 2022-10-28 | Class II | Nonconforming Material/Component | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging. | 24 units | 2026-09-10 |
| 2022-10-28 | Class II | Nonconforming Material/Component | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging. | 22 units | 2026-09-10 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.