iNSitu Bipolar Hip System— 510(k) K191297

Clearance details

Applicant

Theken Companies, LLC

Product code

Code KWY

Device class

Class 2

Regulation

21 CFR 888.3390

Advisory panel

Orthopedic

Date received

2019-05-14

Decision date

2019-09-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Akron, OH, US

• K253357 — b-ONE® Bipolar Head2026-04-13
• K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)2025-08-25
• K231526 — CORAIL Cemented Femoral Stem2023-12-19
• K223441 — SpaceFlex Acetabular Cup2023-03-23
• K221794 — Vario-Cup System2022-07-20

• K192071 — iNSitu Total Hip System2019-08-30
• K172501 — iNSitu Total Hip System2017-09-21
• K161184 — iNSitu Total Hip System2016-10-14

Death

3

Injury

2,049

Total

2,052

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0227-2026 — iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mmClass II·Ongoing·Theken Companies LLC·20250911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191297.