Escalade Acetabular System
Escalade is a modular acetabular system for total hip replacement. A hemispherical titanium-alloy shell is press-fitted into the acetabulum, with a commercially pure titanium plasma-sprayed…
Escalade is a modular acetabular system for total hip replacement. A hemispherical titanium-alloy shell is press-fitted into the acetabulum, with a commercially pure titanium plasma-sprayed coating for biological fixation.
The shell accepts an extensively crosslinked UHMWPE liner. Titanium-alloy cancellous bone screws and an apical screw-hole cover are additional components; a listed 6.5 mm screw belongs to this fixation group.
Listed Item
Dia.6.5x40mm Cancellous Bone Screw Low Profile
Articulation Options
Liners are available with neutral or hooded faces and for femoral heads from 26 to 40 mm. The broader system includes cobalt-chromium heads, with 36 and 40 mm sizes among its options. Shell fixation and liner/head articulation serve different roles in the hip replacement.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Ortho Development Corp., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K103384 |
| Record published | 2015-08-31 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 6.5 to 70 mm; lumen/inner diameter 22 to 40 mm; length 1 to 65 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 171-3252 | Lumen/Inner Diameter 32 mm | In distribution |
| 171-2852 | Lumen/Inner Diameter 28 mm | In distribution |
| 170-0370 | Outer Diameter 70 mm | In distribution |
| 170-0064 | Outer Diameter 64 mm | In distribution |
| 170-0052 | Outer Diameter 52 mm | In distribution |
| 170-2864 | Outer Diameter 64 mm | In distribution |
| 171-3264 | Outer Diameter 64 mm | In distribution |
| 170-3264 | Outer Diameter 64 mm | In distribution |
| 170-3040 | Length 40 mm | In distribution |
| 170-2040 | Length 40 mm | In distribution |
| 170-3035 | Length 35 mm | In distribution |
| 170-0154 | Outer Diameter 54 mm | In distribution |
| 171-3660 | Lumen/Inner Diameter 36 mm | In distribution |
| 170-3060 | Length 60 mm | In distribution |
| 170-3065 | Length 65 mm | In distribution |
| 170-2844 | Length 3 mm | In distribution |
| 170-0148 | Outer Diameter 48 mm | In distribution |
| 170-0056 | Outer Diameter 56 mm | In distribution |
| 170-2852 | Outer Diameter 52 mm | In distribution |
| 171-3658 | Lumen/Inner Diameter 36 mm | In distribution |
| 170-3250 | Length 1 mm | In distribution |
| 170-2050 | Length 50 mm | In distribution |
| 170-4060 | Lumen/Inner Diameter 40 mm | In distribution |
| 170-2854 | Lumen/Inner Diameter 28 mm | In distribution |
| 170-3260 | Outer Diameter 60 mm | In distribution |
| 170-2030 | Outer Diameter 6.5 mm | In distribution |
| 170-2045 | Outer Diameter 6.5 mm | In distribution |
| 171-2642 | Lumen/Inner Diameter 26 mm | In distribution |
| 170-0368 | Outer Diameter 68 mm | In distribution |
| 171-2862 | Outer Diameter 62 mm | In distribution |
| 171-3258 | Outer Diameter 58 mm | In distribution |
| 170-0160 | Outer Diameter 60 mm | In distribution |
| 170-3662 | Outer Diameter 62 mm | In distribution |
| 170-3660 | Lumen/Inner Diameter 36 mm | In distribution |
| 171-2644 | Lumen/Inner Diameter 26 mm | In distribution |
| 170-0301 | In distribution | |
| 170-0170 | Outer Diameter 70 mm | In distribution |
| 170-0342 | Outer Diameter 42 mm | In distribution |
| 170-3262 | Outer Diameter 62 mm | In distribution |
| 171-3262 | Outer Diameter 62 mm | In distribution |
| 171-4062 | Outer Diameter 62 mm | In distribution |
| 170-0358 | Outer Diameter 58 mm | In distribution |
| 170-4058 | Lumen/Inner Diameter 40 mm | In distribution |
| 171-3656 | Outer Diameter 56 mm | In distribution |
| 170-2020 | Length 20 mm | In distribution |
| 171-2854 | Lumen/Inner Diameter 28 mm | In distribution |
| 170-2065 | Length 65 mm | In distribution |
| 171-4064 | Outer Diameter 64 mm | In distribution |
| 170-0140 | Outer Diameter 40 mm | In distribution |
| 170-2848 | Lumen/Inner Diameter 28 mm | In distribution |
| 170-0344 | Outer Diameter 44 mm | In distribution |
| 170-0144 | Outer Diameter 44 mm | In distribution |
| 170-3654 | Lumen/Inner Diameter 36 mm | In distribution |
| 170-0060 | Outer Diameter 60 mm | In distribution |
| 170-3025 | Length 25 mm | In distribution |
| 170-2850 | Lumen/Inner Diameter 28 mm | In distribution |
| 170-3248 | Lumen/Inner Diameter 32 mm | In distribution |
| 171-3662 | Lumen/Inner Diameter 36 mm | In distribution |
| 171-2856 | Lumen/Inner Diameter 28 mm | In distribution |
| 170-0044 | Outer Diameter 44 mm | In distribution |
| 170-2240 | Outer Diameter 40 mm | In distribution |
| 170-0058 | Outer Diameter 58 mm | In distribution |
| 170-2860 | Lumen/Inner Diameter 28 mm | In distribution |
| 171-2850 | Outer Diameter 50 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242833 | 2024-10-11 |
| K173951 | 2018-05-30 |
| K161080 | 2016-05-17 |
| K141001 | 2014-07-30 |
| K132697 | 2014-06-20 |
| K133386 | 2014-03-11 |
| K131022 | 2013-10-16 |
| K103384 | 2011-03-16 |
| K062775 | 2007-01-16 |
| K053293 | 2006-02-16 |
| K042565 | 2005-04-11 |
| K000321 | 2000-04-10 |
| K960660 | 1996-05-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ortho Development Corp. | 510(k) number | 2011-12-19 | Not classified | Device Design | Tip of hex-head screwdriver may break off during use in hip replacement procedure. | 37 units | 2012-08-27 |
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 |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.