NovoHip Total Hip System
+4mm Offset Trial Liner, Neutral Face Sz 52x36
14manufacturers in China registered for this device type
150catalogue numbers in this listing
1510(k) clearance
1recall
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 | Novosource, LLC, 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 |
| 510(k) | K132158 |
| Record published | 2018-02-27 |
| Record revised | 2025-07-22 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 3.2 to 68 mm; length 30 to 109 mm; lumen/inner diameter 28 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1500-1006 | In distribution | |
| 1400-5828 | Outer Diameter 58 mm | In distribution |
| 1500-4545 | Outer Diameter 4.5 mm | In distribution |
| 1404-6640 | Outer Diameter 66 mm | In distribution |
| 1000-1004 | In distribution | |
| 1400-6232 | Outer Diameter 62 mm | In distribution |
| 1100-0007 | Length 95 mm | In distribution |
| 1400-2804 | Outer Diameter 28 mm | In distribution |
| 1445-2803 | Outer Diameter 28 mm | In distribution |
| 1500-1019 | In distribution | |
| 1345-3601 | Outer Diameter 36 mm | In distribution |
| 1445-3202 | Outer Diameter 32 mm | In distribution |
| 1445-2805 | Outer Diameter 28 mm | In distribution |
| 1404-5840 | Outer Diameter 58 mm | In distribution |
| 1500-1020 | In distribution | |
| 1345-2801 | Outer Diameter 28 mm | In distribution |
| 1415-5236 | Outer Diameter 52 mm | In distribution |
| 1400-2802 | Outer Diameter 28 mm | In distribution |
| 1400-0048 | Outer Diameter 48 mm | In distribution |
| 1345-3602 | Outer Diameter 36 mm | In distribution |
| 1500-0068 | Outer Diameter 68 mm | In distribution |
| 1100-0009 | Length 98 mm | In distribution |
| 1450-0003 | Length 87 mm | In distribution |
| 1400-0064 | Outer Diameter 64 mm | In distribution |
| 1400-5840 | Outer Diameter 58 mm | In distribution |
| 1450-0001 | Length 81 mm | In distribution |
| 1445-3602 | Outer Diameter 36 mm | In distribution |
| 1100-0008 | Length 97 mm | In distribution |
| 1415-6640 | Outer Diameter 66 mm | In distribution |
| 1400-3202 | Outer Diameter 32 mm | In distribution |
| 1500-0063 | Outer Diameter 63 mm | In distribution |
| 1404-6628 | Outer Diameter 66 mm | In distribution |
| 1100-0010 | Length 101 mm | In distribution |
| 1345-2802 | Outer Diameter 28 mm | In distribution |
| 1400-1125 | Outer Diameter 11.25 mm | In distribution |
| 1100-0006 | Length 93 mm | In distribution |
| 1125-0007 | Length 95 mm | In distribution |
| 1345-3202 | Outer Diameter 32 mm | In distribution |
| 1500-0028 | Outer Diameter 28 mm | In distribution |
| 1500-4530 | Outer Diameter 4.5 mm | In distribution |
| 1445-3205 | Outer Diameter 32 mm | In distribution |
| 1125-0002 | Length 85 mm | In distribution |
| 1400-3204 | Outer Diameter 32 mm | In distribution |
| 1100-0005 | Length 91 mm | In distribution |
| 1500-1012 | In distribution | |
| 1400-6640 | Outer Diameter 66 mm | In distribution |
| 1125-0008 | Length 97 mm | In distribution |
| 1125-0012 | Length 109 mm | In distribution |
| 1404-5028 | Outer Diameter 50 mm | In distribution |
| 1500-1041 | In distribution | |
| 1500-1017 | In distribution | |
| 1500-0044 | Outer Diameter 44 mm | In distribution |
| 1500-0055 | Outer Diameter 55 mm | In distribution |
| 1500-0047 | Outer Diameter 47 mm | In distribution |
| 1400-5228 | Outer Diameter 52 mm | In distribution |
| 1500-0059 | Outer Diameter 59 mm | In distribution |
| 1415-5828 | Outer Diameter 58 mm | In distribution |
| 1100-0012 | Length 109 mm | In distribution |
| 1450-0008 | Length 97 mm | In distribution |
| 1400-0068 | Outer Diameter 68 mm | In distribution |
| 1450-0006 | Length 93 mm | In distribution |
| 1400-2250 | Outer Diameter 22.5 mm | In distribution |
| 1100-0002 | Length 85 mm | In distribution |
| 1125-1625 | Outer Diameter 16.25 mm | In distribution |
| 1125-0006 | Length 93 mm | In distribution |
| 1450-0007 | Length 95 mm | In distribution |
| 1100-0001 | Length 81 mm | In distribution |
| 1400-0060 | Outer Diameter 60 mm | In distribution |
| 1445-3203 | Outer Diameter 32 mm | In distribution |
| 1445-2801 | Outer Diameter 28 mm | In distribution |
| 1445-3204 | Outer Diameter 32 mm | In distribution |
| 1500-3245 | Outer Diameter 3.2 mm | In distribution |
| 1345-2803 | Outer Diameter 28 mm | In distribution |
| 1400-0056 | Outer Diameter 56 mm | In distribution |
| 1400-5236 | Outer Diameter 52 mm | In distribution |
| 1400-0875 | Outer Diameter 8.75 mm | In distribution |
| 1400-5432 | Outer Diameter 54 mm | In distribution |
| 1450-0010 | Length 101 mm | In distribution |
| 1500-0043 | Outer Diameter 43 mm | In distribution |
| 1125-0011 | Length 105 mm | In distribution |
| 1125-0004 | Length 89 mm | In distribution |
| 1500-0045 | Outer Diameter 45 mm | In distribution |
| 1445-3604 | Outer Diameter 36 mm | In distribution |
| 1415-5840 | Outer Diameter 58 mm | In distribution |
| 1345-3604 | Outer Diameter 36 mm | In distribution |
| 1410-4000 | Outer Diameter 40 mm | In distribution |
| 1404-6232 | Outer Diameter 62 mm | In distribution |
| 1125-0003 | Length 87 mm | In distribution |
| 1400-3604 | Outer Diameter 36 mm | In distribution |
| 1500-0049 | Outer Diameter 49 mm | In distribution |
| 1404-5432 | Outer Diameter 54 mm | In distribution |
| 1500-1014 | In distribution | |
| 1404-5828 | Outer Diameter 58 mm | In distribution |
| 1400-6628 | Outer Diameter 66 mm | In distribution |
| 1500-1010 | In distribution | |
| 1100-0004 | Length 89 mm | In distribution |
| 1125-0010 | Length 101 mm | In distribution |
| 1415-5228 | Outer Diameter 52 mm | In distribution |
| 1450-0005 | Length 91 mm | In distribution |
| 1345-3603 | Outer Diameter 36 mm | In distribution |
| 1500-1050 | In distribution | |
| 1200-5836 | Lumen/Inner Diameter 36 mm | In distribution |
| 1445-2802 | Outer Diameter 28 mm | In distribution |
| 1450-0002 | Length 85 mm | In distribution |
| 1100-0003 | Length 87 mm | In distribution |
| 1000-1002 | In distribution | |
| 1500-0036 | Outer Diameter 36 mm | In distribution |
| 1500-1008 | In distribution | |
| 1345-3203 | Outer Diameter 32 mm | In distribution |
| 1500-3230 | Outer Diameter 3.2 mm | In distribution |
| 1445-2804 | Outer Diameter 28 mm | In distribution |
| 1415-5028 | Outer Diameter 50 mm | In distribution |
| 1400-4004 | Outer Diameter 40 mm | In distribution |
| 1400-3602 | Outer Diameter 36 mm | In distribution |
| 1415-5432 | Outer Diameter 54 mm | In distribution |
| 1445-3605 | Outer Diameter 36 mm | In distribution |
| 1500-0051 | Outer Diameter 51 mm | In distribution |
| 1410-3200 | Outer Diameter 32 mm | In distribution |
| 1125-0009 | Length 98 mm | In distribution |
| 1400-4002 | Outer Diameter 40 mm | In distribution |
| 1404-5236 | Outer Diameter 52 mm | In distribution |
| 1415-6232 | Outer Diameter 62 mm | In distribution |
| 1400-0052 | Outer Diameter 52 mm | In distribution |
| 1445-3201 | Outer Diameter 32 mm | In distribution |
| 1435-2803 | 16/18-12/14 L | In distribution |
| 1500-1002 | In distribution | |
| 1125-0005 | Length 91 mm | In distribution |
| 1500-0053 | Outer Diameter 53 mm | In distribution |
| 1345-3201 | Outer Diameter 32 mm | In distribution |
| 1400-1775 | Outer Diameter 17.75 mm | In distribution |
| 1450-0009 | Length 98 mm | In distribution |
| 1450-0004 | Length 89 mm | In distribution |
| 1400-5028 | Outer Diameter 50 mm | In distribution |
| 1404-5228 | Outer Diameter 52 mm | In distribution |
| 1415-6628 | Outer Diameter 66 mm | In distribution |
| 1500-1004 | In distribution | |
| 1450-0012 | Length 109 mm | In distribution |
| 1500-3201 | Outer Diameter 32 mm | In distribution |
| 1500-0057 | Outer Diameter 57 mm | In distribution |
| 1445-3603 | Outer Diameter 36 mm | In distribution |
| 1445-3601 | Outer Diameter 36 mm | In distribution |
| 1100-0011 | Length 105 mm | In distribution |
| 1435-2801 | 16/18-12/14 S | In distribution |
| 1345-3204 | Outer Diameter 32 mm | In distribution |
| 1500-0067 | Outer Diameter 67 mm | In distribution |
| 1500-4001 | Outer Diameter 40 mm | In distribution |
| 1400-0622 | 6.0-22.5 | In distribution |
| 1450-0011 | Length 105 mm | In distribution |
| 1400-1375 | Outer Diameter 13.75 mm | In distribution |
| 1500-1016 | 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 |
|---|---|
| K132158 | 2014-02-21 |
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 |
|---|---|---|---|---|---|---|
| Novosource, LLC | 510(k) number | 2024-09-19 | Class II | Mixed-up of materials/components | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted | 1 unit |
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.