510(k) · Cleared

Cleared

Spacer G Temporary Hip Prosthesis

K031841510(k) TraditionalCleared Jan 22, 2004220-day reviewClass II21 CFR 888.3360

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

Exactech, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal

Cleared on Jan 22, 2004 as substantially equivalent to K974807 (Osteonics Corp., 1998) after a 220-day review. Its family tree reaches back 1 generation to 1998. 32 later devices descend from it.

Decided: Jan 22, 2004
Review: 220 days
Class: Class II
Product code: KWL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K974807 (1998). 32 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK974807 Osteo Austin Moore Endoprosthesis SystemOsteonics Corp. · 1998
This deviceK031841 Spacer G Temporary Hip ProsthesisExactech, Inc. · 2004
Descendant · cites it directly · 30 of its ownK052990 Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis…Biomet, Inc. · 2005 · Recalled
Descendant · cites it directly · 20 of its ownK062273 Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008
Descendant · 2 generations on · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
Descendant · 3 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
Descendant · 4 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2005high 6 (2019) · low 0 (2006)2026

Most influential descendants

Showing 5 of 32 · See all

K052990Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…Biomet, Inc. · 2005 · cites it directly30descendants
K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008 · cites it directly20descendants
K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · 2 generations on19descendants
K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 3 generations on16descendants
K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974807	Osteo Austin Moore Endoprosthesis System	Osteonics Corp.	1998	—
0 (this device)	K031841	Spacer G Temporary Hip Prosthesis	Exactech, Inc.	2004	—
+1	K052990	Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with…	Biomet, Inc.	2005	5
+1	K062273	Spacer-G Temporary Hip Prosthesis	Tecres S.P.A.	2008	—
+2	K101356	Spacer-G and Spacer-K	Tecres S.P.A.	2011	—
+3	K112470	2GC Hip/Knee Modular Spacer	Mandell Horwitz Consultants, LLC	2012	—
+4	K183017	Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer	Osteoremedies, LLC	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	2	0
2011	1	0
2012	1	0
2014	1	0
2016	2	0
2018	1	0
2019	6	0
2020	2	0
2021	1	0
2022	3	0
2023	2	0
2024	3	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K031841, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KWL? 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 KWL device

#1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K974807	Osteo Austin Moore Endoprosthesis System Summary page 2 …s substantially equivalent to the "Osteo Austin Moore Endoprosthesis" (Osteonics Corporation). The "Osteo" device was cleared for marketing through premarket submission #K974807. Model Manufacturer 510(k) Number Osteo Austin Moore Osteonics…	Osteonics Corp.	1998	—

Also cleared against K974807: 1 other device →

What descends from it? (32)

See all 32

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052990	Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…	Biomet, Inc.	2005	30
K062273	Spacer-G Temporary Hip Prosthesis	Tecres S.P.A.	2008	20
K080979	Stageone Select Cement Spacer Molds for Temporary Hip Replacement	Biomet Manufacturing Corp	2008	3
K252326	InterSpace GV Hip Spacer	Tecres S.P.A.	2025	0
K192041	G21 SpaceFlex Hip	G21, S.R.L.	2019	0

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?

Its one ancestor has no recall.
Of its descendants, K052990 (Biomet, Inc., 2005) has gone furthest, with 30 descendants of its own.
1 other device also cites its predicate K974807.

How does its category compare?

All KWL devices

KWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWL

3in 2025

2007high 3 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWL

32in 2025

2007high 32 (2025)2026

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

Recalls per year · KWL

2in 2017

2007high 36 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWL

29in 2025

2007high 415 (2019) · low 11 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	36	11
2008	1	—	0	13
2009	0	—	2	21
2010	0	—	0	55
2011	2	—	0	51
2012	1	—	0	62
2013	0	—	0	89
2014	0	—	0	107
2015	1	—	1	223
2016	0	—	0	210
2017	0	—	2	347
2018	2	—	0	294
2019	1	—	0	415
2020	1	—	0	270
2021	0	—	0	107
2022	1	—	0	99
2023	0	—	0	48
2024	1	—	0	143
2025	3	32	0	29
2026	2	—	1	—

What is it indicated for?

Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in patients undergoing a two-stage procedure due to a septic process.

The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031841 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031841: Spacer G Temporary Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031841

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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