510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Lubinus SP II Hip System

K953653510(k) TraditionalCleared Nov 6, 199595-day reviewClass II21 CFR 888.3360Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Turnkey Intergration USA, Inc. · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

Cleared on Nov 6, 1995 after a 95-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 5 times.

Decided
Nov 6, 1995
Review
95 days
Class
Class II
Product code
JDG
Recalls
5
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K953653Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JDG device

  1. #1 K212431 Biomet Answer/Impact/Integral Distal…score 3.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 15, 2025Class IIZ-2288-2025Under Investigation by firmInconsistent size terminology and color coding used on labeling
Feb 6, 2024Class IIZ-1299-2024Under Investigation by firmDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Feb 6, 2024Class IIZ-1297-2024Under Investigation by firmDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Feb 6, 2024Class IIZ-1298-2024Under Investigation by firmDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Feb 6, 2024Class IIZ-1296-2024Under Investigation by firmDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JDG devices

JDG Prosthesis, Hip, Femoral Component, Cemented, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDG

1in 2022

2018: 12020: 12022: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDG

Too few JDG 510(k)s in any year since 2007 to give a median.

Recalls per year · JDG

4in 2021

2009: 22013: 32021: 4
2007high 4 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDG

263in 2025

2007: 282008: 192009: 382010: 372011: 252012: 492013: 842014: 1452015: 3912016: 3832017: 3282018: 4472019: 3332020: 1,0462021: 1,2062022: 8862023: 2892024: 3002025: 263
2007high 1,206 (2021) · low 19 (2008)2025

MAUDE reports naming product code JDG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—028
20080—019
20090—238
20100—037
20110—025
20120—049
20130—384
20140—0145
20150—0391
20160—0383
20170—0328
20181—0447
20190—0333
20201—01,046
20210—41,206
20221—0886
20230—0289
20240—0300
20250—0263
20260—0—

More from Turnkey Intergration USA, Inc.

26 FDA decisions under this applicant name. See the company

  • K991405Omni-Fix, Humeral NailTurnkey Intergration USA, Inc. · 1999
  • K990523B2C, Espace Revision Cup SystemTurnkey Intergration USA, Inc. · 1999
  • K990307Omni-Fix, Nail SystemTurnkey Intergration USA, Inc. · 1999
  • K972411Link Cement PlugTurnkey Intergration USA, Inc. · 1997
  • K970284Artos, Diplos SystemTurnkey Intergration USA, Inc. · 1997

Recent decisions in JDG

The JDG category page

  • K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc. · 2022
  • K193546Distal CentralizersBiomet, Inc. · 2020
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K001984Progeny Forged Cocr Cemented Femoral ComponentStelkast Company · 2000
  • K992234The Taper-Fit Total Hip SystemCorin USA · 1999

https://510kreport.com/device/K953653 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953653: Lubinus SP II Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953653

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026