510(k) Report

510(k) · Cleared

Cleared

G2 Total Hip System Femoral Stem (11/13 Taper)

K982812510(k) TraditionalCleared Dec 4, 1998115-day reviewClass II21 CFR 888.3390

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

Johnson & Johnson Professionals, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Cleared on Dec 4, 1998 as substantially equivalent to K964769 (Zimmer, Inc., 1997) and 7 other predicates after a 115-day review. Its family tree reaches back 3 generations to 1985.

Decided
Dec 4, 1998
Review
115 days
Class
Class II
Product code
KWY
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K850055 (1985). 15 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 2 other ancestors1996: 2 other ancestors1995: 1 other ancestor1994: 4 other ancestors1993: 1 other ancestor1990: 1 other ancestor1987: 1 other ancestorK850055 · Profile Femoral Hip · Depuy, Inc. · 1985K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK964769 · Versys Hip System--Fiber Metal Taper Hip Prosthesis · Zimmer, Inc. · 19971985199019952000
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor K964769 · Versys Hip System--Fiber Metal Taper Hip Prosthesis · Zimmer, Inc. · 1997K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK850055 · Profile Femoral Hip · Depuy, Inc. · 19850
  1. Root · 3 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 2 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 1 generation backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
  4. This deviceK982812 G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K850055Profile Femoral HipDepuy, Inc.1985—
−2K961378Delta Hip ProsthesisZimmer, Inc.19964
−1K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc.1997—
0 (this device)K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010
199310
199440
199510
199620
199720
FIG. 1 — Lineage of K982812, 1985–1998Source: FDA 510(k) summaries, read by 510(k) Report · 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWY? 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 KWY device

  1. #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K964769Versys Hip System--Fiber Metal Taper Hip Prosthesis
Summary page 2
…Hip System Femoral Stems are substantially equivalent in material and function to the following list of commercially distributed products: Zimmer Versys™ Enhanced Taper K964769 Hip System Zimmer Heritage™ Hip System K963109 Wright Resolution™ Microtextured K933570 Femoral Component Howmedica Precision Ost…
Zimmer, Inc.1997—
*K963109Heritage Hip System
Summary page 2
…valent in material and function to the following list of commercially distributed products: Zimmer Versys™ Enhanced Taper K964769 Hip System Zimmer Heritage™ Hip System K963109 Wright Resolution™ Microtextured K933570 Femoral Component Howmedica Precision Osteolock™ K944592 Hip System Johnson & Johnson Pr…
Zimmer, Inc.19973
*K933570Resolution (TM) Hip Stem
Summary page 2
…llowing list of commercially distributed products: Zimmer Versys™ Enhanced Taper K964769 Hip System Zimmer Heritage™ Hip System K963109 Wright Resolution™ Microtextured K933570 Femoral Component Howmedica Precision Osteolock™ K944592 Hip System Johnson & Johnson Professional, Inc. K945518 P.F.C.® 2 Hip Sy…
Wrightmedicaltechnologyinc1994—
*K944592Precision Osteolock Femoral Component
Summary page 2
…r Versys™ Enhanced Taper K964769 Hip System Zimmer Heritage™ Hip System K963109 Wright Resolution™ Microtextured K933570 Femoral Component Howmedica Precision Osteolock™ K944592 Hip System Johnson & Johnson Professional, Inc. K945518 P.F.C.® 2 Hip System Johnson & Johnson Professional, Inc. K963885 ULTIMA®…
Howmedica Corp.1995—
*K945518P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component
Summary page 2
…age™ Hip System K963109 Wright Resolution™ Microtextured K933570 Femoral Component Howmedica Precision Osteolock™ K944592 Hip System Johnson & Johnson Professional, Inc. K945518 P.F.C.® 2 Hip System Johnson & Johnson Professional, Inc. K963885 ULTIMA® Fx Femoral Hip System Johnson & Johnson Professional, I…
Johnson & Johnson Professionals, Inc.1996—
*K963885Ultima FX Femoral Hip Stems
Summary page 2
…emoral Component Howmedica Precision Osteolock™ K944592 Hip System Johnson & Johnson Professional, Inc. K945518 P.F.C.® 2 Hip System Johnson & Johnson Professional, Inc. K963885 ULTIMA® Fx Femoral Hip System Johnson & Johnson Professional, Inc. K972435 ULTIMA® LX Femoral Hip System K924379…
Johnson & Johnson Professionals, Inc.1996—
*K972435Ultima and Ultima LX Cemented Femoral Stem
Summary page 2
…& Johnson Professional, Inc. K945518 P.F.C.® 2 Hip System Johnson & Johnson Professional, Inc. K963885 ULTIMA® Fx Femoral Hip System Johnson & Johnson Professional, Inc. K972435 ULTIMA® LX Femoral Hip System K924379 (2 anny, *.’ “lnc,‘_%' N DEPARTMENT OF HEALTH & HUMAN SERVICES Public H…
Johnson & Johnson Professionals, Inc.19979
*K924379Ultima (TM) Total Hip System Cemented Femoral Stem
Summary page 2
….F.C.® 2 Hip System Johnson & Johnson Professional, Inc. K963885 ULTIMA® Fx Femoral Hip System Johnson & Johnson Professional, Inc. K972435 ULTIMA® LX Femoral Hip System K924379 (2 anny, *.’ “lnc,‘_%' N DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administr…
Johnson & Johnson Orthopaedics, Inc.1993—

Also cleared against K964769: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 5 of the 15 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K964769.

How does its category compare?

All KWY devices

KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWY

1in 2025

2008: 32009: 12010: 42011: 12012: 12013: 22014: 12015: 12016: 12017: 12018: 32019: 52020: 12022: 22023: 22025: 12026 (partial year): 1
2007high 5 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWY

126in 2019

2008: 123 days median2010: 187 days median2018: 219 days median2019: 126 days median
2007high 219 (2018) · low 123 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWY

2in 2025

2007: 252009: 242010: 12012: 12013: 22016: 32017: 22018: 12019: 12024: 12025: 2
2007high 25 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWY

180in 2025

2007: 3702008: 9002009: 9612010: 6882011: 7582012: 9782013: 1,1482014: 1,0552015: 1,2132016: 8772017: 8262018: 1,3802019: 1,5302020: 1,2592021: 2762022: 2082023: 1782024: 2092025: 180
2007high 1,530 (2019) · low 178 (2023)2025

MAUDE reports naming product code KWY, 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—25370
200831230900
20091—24961
201041871688
20111—0758
20121—1978
20132—21,148
20141—01,055
20151—01,213
20161—3877
20171—2826
2018321911,380
2019512611,530
20201—01,259
20210—0276
20222—0208
20232—0178
20240—1209
20251—2180
20261—0—

What is it indicated for?

The G2 Total Hip System Femoral Stems (11/13 Taper) are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatiod arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenial hip dysplasia…

Read the full statement (117 words)

The G2 Total Hip System Femoral Stems (11/13 Taper) are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatiod arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenial hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

The G2 Polished Femoral Stem (11/13 taper) is indicated for use only with PMMA bone cement.

The G2 Microtextured Femoral Stem (11/13 taper) is not indicated for use with PMMA bone cement.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K964769

6 other devices cite the same predicate.

  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall
  • K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
  • K051491Trabecular Metal Primary Hip ProsthesisZimmer, Inc. · 20055 recalls
  • K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 20033 recalls
  • K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 20032 recalls
  • K984492Tigran Hip ProsthesisPonmed, Ltd. · 1999

More from Johnson & Johnson Professionals, Inc.

206 FDA decisions under this applicant name. See the company

  • K992173Siphonguard CSF Control DeviceJohnson & Johnson Professionals, Inc. · 2000
  • K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
  • K991222Codman Microsensor Ventricular Catheter KitJohnson & Johnson Professionals, Inc. · 1999
  • K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998
  • K983141Capitello-Condylar Total Elbow ProsthesisJohnson & Johnson Professionals, Inc. · 1998

Recent decisions in KWY

The KWY category page

  • K253357b-ONE® Bipolar HeadB-One Ortho, Corp. · 2026
  • K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc. · 2025
  • K231526CORAIL Cemented Femoral StemDepuy Ireland UC · 2023
  • K223441SpaceFlex Acetabular CupG21, S.R.L. · 2023
  • K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG · 2022

https://510kreport.com/device/K982812 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982812: G2 Total Hip System Femoral Stem (11/13 Taper).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982812

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026